Relevant bibliographies by topics / Medical devices certification

Contents

  1. Journal articles
  2. Dissertations / Theses
  3. Books
  4. Book chapters
  5. Conference papers

Academic literature on the topic 'Medical devices certification'

Author: Grafiati
Published: 30 May 2022
Last updated: 31 May 2022

Create a spot-on reference in APA, MLA, Chicago, Harvard, and other styles

Select a source type:

Consult the lists of relevant articles, books, theses, conference reports, and other scholarly sources on the topic 'Medical devices certification.'

Next to every source in the list of references, there is an 'Add to bibliography' button. Press on it, and we will generate automatically the bibliographic reference to the chosen work in the citation style you need: APA, MLA, Harvard, Chicago, Vancouver, etc.

You can also download the full text of the academic publication as pdf and read online its abstract whenever available in the metadata.

Journal articles on the topic "Medical devices certification"

1

Glinski, Carola, and Peter Rott. "Regulating Certification Bodies in the Field of Medical Devices: The PIP Breast Implants Litigation and Beyond." European Review of Private Law 27, Issue 2 (April 1, 2019): 403–28. http://dx.doi.org/10.54648/erpl2019021.

Full text
Abstract:
This article uses the breast implants scandal around the French producer Poly Implant Prothèse (PIP) to discuss the regulation of medical devices in EU law. Thereby, the specific focus is on the role of tort liability of certification bodies in complementing the public law regime of medical devices law. As tort law has not been harmonized yet at the level of EU law, national legal systems may produce different results; which indeed the PIP case demonstrates, with diverging judgments from French and German courts. Showing the deficiencies of the public law system of the Medical Devices Directive of 1993 as well as of the new Medical Devices Regulation of 2017, the article argues that tort liability is a necessary regulatory instrument to ensure that certification bodies live up to their duties under medical devices law and therefore a necessary instrument for the protection of the health and safety of patients.
APA, Harvard, Vancouver, ISO, and other styles
2

Geremia, Fabio. "Quality aspects for medical devices, quality system and certification process." Microchemical Journal 136 (January 2018): 300–306. http://dx.doi.org/10.1016/j.microc.2017.04.018.

Full text
APA, Harvard, Vancouver, ISO, and other styles
3

Umamaheswara Rao, Ganne. "“Made in India”: How’s that for an indigenous medical device?" Indian Journal of Neurosurgery 02, no. 02 (May 2013): 151–53. http://dx.doi.org/10.4103/2277-9167.118115.

Full text
Abstract:
Abstract With increasing costs of imported equipment, there is a need for Indigenization of medical devices in India. The resources including skilled manpower to develop equipment of a good standard are available in the country. What plagues the developmental process is the lack of adequate interaction between the medical profession and the technologists and reluctance of the industry to venture into the medical device manufacturing. A much bigger and more serious road-block is the lack of formal certification and regulatory processes for these devices. Medical practitioners should be open to evaluating and accepting indigenous equipment that pass the requisite standards. Formal mechanisms should be developed to orient both physicians and engineers to the technical and commercial issues of device development.
APA, Harvard, Vancouver, ISO, and other styles
4

Kaule, Sebastian, Andrea Bock, Ariane Dierke, Stefan Siewert, Klaus-Peter Schmitz, Michael Stiehm, Ernst Klar, et al. "Medical Device Regulation and current challenges for the implementation of new technologies." Current Directions in Biomedical Engineering 6, no. 3 (September 1, 2020): 334–37. http://dx.doi.org/10.1515/cdbme-2020-3086.

Full text
Abstract:
AbstractThe European Parliament and the European Council on May 26, 2017 decided to introduce the new regulatory framework for medical devices. The transitional period of the so called Medical Device Regulation (EU 2017/745, MDR) should end on May 26, 2020. Currently the European Commission is working on a proposal to postpone the application for one year to relieve pressure from all stakeholders allowing them to fully focus on priorities related to the coronavirus crisis. From this date or most likely from May 26, 2021, manufacturers must present a CE-certificate according to the new MDR requirements not only for novel medical devices, but also for approved medical devices which are already on the market. The MDR will significantly complicate the process of bringing medical devices into market due to the increased requirements for the CE-certification process, particularly concerning increased documentation effort. This involves a risk for the translation of innovative products due to an overload of the overall system (manufacturers, Notified Bodies, experts) and might lead to shrinkage of the product range of existing products. Thankfully, adaption of transitional periods, special regulations, extensions of deadlines and most probably postponement of the MDR application date will ensure that there will be no gaps in medical supply that endanger patients. Establishing and keeping the relevant regulatory expertise up to date and devoting the necessary financial, time and human resources that is the biggest immediate challenge the medium-sized medical technology sector is facing in the near future. The current article, written about one month before the initially expected end of the first transition period on May 26, 2020, summarized the main aspects of the current state of MDR implementation with respect to regulatory novelties, the current legal basis in Germany, transition periods and changes in the requirements of CE-certification relevant technical documentation. Furthermore, challenges for existing and innovative medical devices were shortly discussed using a new stent based therapy of the proximal Fallopian tubal stenosis and transcatheter aortic valve implantation as two examples.
APA, Harvard, Vancouver, ISO, and other styles
5

Janß, Armin, Johannes Thorn, Malte Schmitz, Alexander Mildner, Jasmin Dell’Anna-Pudlik, Martin Leucker, and Klaus Radermacher. "Extended device profiles and testing procedures for the approval process of integrated medical devices using the IEEE 11073 communication standard." Biomedical Engineering / Biomedizinische Technik 63, no. 1 (February 23, 2018): 95–103. http://dx.doi.org/10.1515/bmt-2017-0055.

Full text
Abstract:
AbstractNowadays, only closed and proprietary integrated operating room systems (IORS) from big manufacturers are available on the market. Hence, the interconnection of components from third-party vendors is only possible with increased time and costs. In the context of the German Federal Ministry of Education and Research (BMBF)-funded project OR.NET (2012–2016), the open integration of medical devices from different manufacturers was addressed. An integrated operating theater based on the open communication standard IEEE 11073 shall give clinical operators the opportunity to choose medical devices independently of the manufacturer. This approach would be advantageous especially for hospital operators and small- and medium-sized enterprises (SME) of medical devices. Actual standards and concepts regarding technical feasibility and the approval process do not cope with the requirements for a modular integration of medical devices in the operating room (OR), based on an open communication standard. Therefore, innovative approval strategies and corresponding certification and test procedures, which cover actual legal and normative standards, have to be developed in order to support the future risk management and the usability engineering process of open integrated medical devices in the OR. The use of standardized device and service profiles and a three-step testing procedure, including conformity, interoperability and integration tests are described in this paper and shall support the manufacturers to integrate their medical devices without disclosing the medical devices’ risk analysis and related confidential expertise or proprietary information.
APA, Harvard, Vancouver, ISO, and other styles
6

Mijares, Rodrigo, Néstor Utrera, Zhayda Sierra, Sara González, Rubén Lugo, María Rincón, and Raquel Mijares. "Quality Certification of Medical Devices in Venezuela: Process Developed by Simón Bolívar University, Caracas-Venezuela." Global Clinical Engineering Journal 2, no. 3 (May 4, 2020): 8–14. http://dx.doi.org/10.31354/globalce.v2i3.83.

Full text
Abstract:
Background and objective: medical devices and supplies increase productivity in health institutions, contributing to the reduction of morbidity and mortality rates. However, the use of medical devices has an associated level of risk. A third party must guarantee the safety and effectiveness of the medical team to grant a quality certification. In Venezuela, one of the institutions authorized by the regulatory entity (Ministry of Popular Power for Health) that grants quality certification is the Health Technology Management Unit (UGTS) attached to the Research and Development Foundation (FUNINDES ) from the Simón Bolívar University (USB). The objective of this work is to show the certification protocol by the UGTS and its results. Material and Methods; It based on the ISO 9001 standard for the processes. Five activities were determined: Prepare the teaching, technical and administrative staff as ISO auditors. Carry out an external audit, in order to make proposals for improvement; Plan changes in our quality management system and processes and Qualify as a supplier guided by the ISO 9001 philosophy by a prestigious international company. Results: Based on the results, general and particular proposals were proposed to improve the process. These were adopted by the group and later in the evaluation of an international company the USB was qualified as an approved supplier for the analysis of medical devices by the company Johnson & Johnson Medical S.C.S. when complying with ISO 9001 Standard. Conclusions: The UGTS is authorized by the Ministry of Popular Power for Health (MPPS) through the Sanitary Comptroller's Office to issue quality certificates to medical teams since 1999. Approximately 55 companies that have received service are registered in its database. In the period audited (2012 - 2014), 25 files were created. Its processes comply with ISO 9001.
APA, Harvard, Vancouver, ISO, and other styles
7

Foo, Jong Yong Abdiel, and Xin Ji Alan Tan. "Limited Awareness of the Essences of Certification or Compliance Markings on Medical Devices." Science and Engineering Ethics 23, no. 3 (November 28, 2016): 653–61. http://dx.doi.org/10.1007/s11948-016-9836-4.

Full text
APA, Harvard, Vancouver, ISO, and other styles
8

Abela, E., P. Farrugia, M. V. Gauci, P. Vella, G. Cassar, and E. Balzan. "A Novel User-Centred Framework for the Holistic Design of Therapeutic Medical Devices." Proceedings of the Design Society 2 (May 2022): 1199–208. http://dx.doi.org/10.1017/pds.2022.122.

Full text
Abstract:
AbstractNumerous and complex sequence of activities in medical device development often result in time consuming and expensive engineering processes. In this study, patient and designer requirements were identified and integrated within a novel framework which supports medical device design through a consolidated understanding of user-experience whilst directly coalescing the applicable regulatory requirements in terms of product compliance and certification. This assists in the development of safe and reliable products which reflect the need for increased usability considerations during design.
APA, Harvard, Vancouver, ISO, and other styles
9

Zarmani, Nur Farhani, Mohd Anuar Ramli, Shaikh Mohd Saifuddeen Shaikh Mohd Salleh, Mohd Zaid Daud, and Mohd Amzari Tumiran. "ANALYSIS ON THE HALAL STATUS OF A MEDICAL DEVICE: A STUDY ON THE SURGICAL SUTURE." International Journal of Halal Ecosystem and Management Practices 1, no. 1 (September 15, 2021): 01–07. http://dx.doi.org/10.35631/ijhemp.11001.

Full text
Abstract:
There is a recent demand for halal certification from another healthcare sector which is medical devices, which cover all types of medical equipment used in hospitals from simple equipment such as bandages to complex equipment such as ventilators. This matter has been raised by the industry as halal labelling is a requirement to penetrate the market of Islamic countries such as Saudi Arabia, Turkey, and Pakistan. Even it seems critical to proving halal status for the medical devices that incorporate animal tissues, in contact with or invasive to the body, and produce a reaction to the body, this does not deny the demand for other types of devices. This study will focus on the halal issues related to medical devices which are widely used to stitch and close the wounds of patients after surgery or injury, namely sutures. This study seeks to identify the status of suture usage from the perspective of Islamic ruling. To achieve this objective, a qualitative research method through library research, as well as field studies involving in-depth interviews with the industry players, both medical device and religious authorities, Islamic scholars, and medical practitioners. The interviews were recorded, transcribed, translated, coded, and reconciled with the aid of Atlas.ti software (version 7) to identify themes and subthemes for this study. The results show that with regard to the status of resources and processes, and the application of al-darurah (necessity) concept.
APA, Harvard, Vancouver, ISO, and other styles
10

Maresova, Petra, Ladislav Hajek, Ondrej Krejcar, Michael Storek, and Kamil Kuca. "New Regulations on Medical Devices in Europe: Are They an Opportunity for Growth?" Administrative Sciences 10, no. 1 (March 12, 2020): 16. http://dx.doi.org/10.3390/admsci10010016.

Full text
Abstract:
Increasing demand for modern treatments and significant profit margins are strong incentives for investors and producers. However, the production and use of medical devices is subject to a number of laws, regulations, strict standards, and certification processes. Therefore, the aim of this paper is to analyze patent activity based on the example of the selected country (Czech Republic), compare it with selected foreign countries, and discuss the development of this industry in the context of new medical device regulation (MDR) implementation. The paper is based on the theoretical concept of the relationship between regulation and innovation. The main challenge in the implementation of the new medical device regulations lies in the area of innovation. This is because most innovative research in the medical device sector is undertaken by small to medium enterprises (SMEs) rather than by large companies. SMEs are more vulnerable than big companies when it comes to development because the accompanying administrative costs can be so high that it may force the company to leave the market. Given that the main reason for the existence of economic regulations are various forms of market failure, which occurs when market mechanisms do not lead to results that benefit society, any attempts to redress this situation should naturally lead to greater benefits for society and hence benefits for the given industry as well.
APA, Harvard, Vancouver, ISO, and other styles
More sources

Dissertations / Theses on the topic "Medical devices certification"

1

Pulla, Aleksandër, and Antonela Bregu. "Evaluating the Compliance Re-Certification Efficiency Enabled by the AMASS Platform for Medical Devices." Thesis, Mälardalens högskola, Akademin för innovation, design och teknik, 2020. http://urn.kb.se/resolve?urn=urn:nbn:se:mdh:diva-48580.

Full text
Abstract:
The certification of systems in the medical domain aims to ensure that a system is acceptably safein order to bear the CE mark. Such process is exhaustive, expensive, time-consuming and safety-critical.Medical devices shall be re-certified under Medical Device Regulations. The first de-facto platform for re-certification is delivered by AMASS project. This thesis is expected to fill the specific gap: evaluate the compliance re-certification efficiency of the platform in the medical domain during the re-certification effort required as a consequence of a change in the normative space. Due to the lack of demonstrations in this safety-critical domain, the standard for medical devices, ISO 14971 with its versions and the Notified Bodies Recommendation Group (NBRG) Consensus paper are considered. There are several differences among them, in terms of the normative part and the fact whether they are international or only applicable in Europe. The evaluation will be conducted on acase study and the research has followed best practicing in case study design/execution. The focus is on two changes. The first change in the normative space is represented by the introduction of the EU directives (EU Medical Device Directives (MDDs): 90/385/EEC, 93/42/EEC, and 98/79/EC.) in relation to ISO 14971:2007, which required the introduction of ISO 14971:2012 (which applies only to manufacturers placing devices on the market in Europe). The second change is represented by the introduction of ISO 14971:2019, an international standard. Through the tool-chain (EPF Composer-BVR Tool), the families of standards and processes are modeled. The reuse of components is assessed through the application of selected metrics creating the measurement framework.The aim is to increase evidence according to the usefulness of the tool-chain in other domains. This master thesis will contribute with a case study evaluation of the tool-chain (a subset of the platform), considering cross-jurisdictional challenges. This work could represent the starting point for an evaluation where not only reference-processes are considered, but also the processes actually modelled in industrial settings.
APA, Harvard, Vancouver, ISO, and other styles
2

Томашевський, Роман Сергійович, and Костянтин Васильович Колісник. "Особливості метрологічного контролю якості цифрового портативного турбінного спірометра ЦПС-14/1." Thesis, Издательский центр "Политехпериодика", 2017. http://repository.kpi.kharkov.ua/handle/KhPI-Press/34054.

Full text
Abstract:
Сучасна медична апаратура, що використовує мікропроцесорне керування, дозволяє отримувати значно кращі, ніж раніше, показники якості щодо забезпечення медичних послуг. Цілком природнім є зростання вимог до метрологічного забезпечення та засобів, що використовуються під час її сертифікації. Показано особливості метрологічного контролю якості розробленого цифрового портативного турбінного спірометра ЦПС-14/1.
Modern medical equipment that uses microprocessor control allows providing much better quality of medical service. The authors show compliance with the regulatory documentation for the certification of medical products on the basis of their own design.
APA, Harvard, Vancouver, ISO, and other styles
3

Gomes, Catarina Martins. "Traineeship in Lenitudes Medical Center & Research : quality management." Master's thesis, Universidade de Aveiro, 2015. http://hdl.handle.net/10773/14578.

Full text
Abstract:
Mestrado em Biomedicina Farmacêutica
This document aims to describe a traineeship developed in the healthcare unit Lenitudes Medical Center & Research, located in Santa Maria da Feira, which had a duration of 10 months, following the process of construction, opening and start functioning of this new health facility. The academic training provided during module courses of the Master Degree in Pharmaceutical Biomedicine allowed the development of knowledge and skills in the areas of Clinical Research, Regulatory and Medical Devices Development and Quality Management which have been put into practice during this experience. The traineeship focused, essentially, on topics related to quality management, respective documentation and development processes of its system, with the objective to outline future strategies for this clinic’s accreditation and certification. During this traineeship, I additionally developed multidisciplinary activities related to search, organization of medical devices’ budgets and selection and, also, some initial processes regarding clinical research. The traineeship has proved very enriching and unique, having enabled the development of new professional, personal and social skills.
O presente documento pretende descrever um estágio curricular realizado na clínica Lenitudes Medical Center & Research, localizada em Santa Maria da Feira, que decorreu durante 10 meses, acompanhando o processo de construção, abertura e entrada em funcionamento desta nova estrutura de saúde. A formação académica proporcionada pelas unidades curriculares do Mestrado em Biomedicina Farmacêutica permitiu o desenvolvimento de conhecimentos e competências nas áreas de Investigação Clínica, Regulamentação e Desenvolvimento de Dispositivos Médicos e Gestão da Qualidade que puderam ser colocados em prática durante esta experiência. O estágio focou essencialmente tópicos relacionados com a Gestão da Qualidade, com os respetivos processos de desenvolvimento do seu Sistema e da respetiva documentação, visando possíveis estratégias futuras para a Acreditação e Certificação desta unidade de saúde. Durante o estágio, adicionalmente, foram realizadas atividades de carácter multidisciplinar relacionadas com a procura, organização de propostas de orçamento e seleção de dispositivos médicos e, ainda, alguns processos iniciais de investigação clínica. O estágio curricular revelou-se bastante enriquecedor e único, tendo permitido o desenvolvimento de novas competências e aptidões profissionais, pessoais e sociais.
APA, Harvard, Vancouver, ISO, and other styles
4

Imani, Shabnam, and Elnaz Farzaneh. "Electromagnetic Compatibility Requirements for Medical Device Certification." Thesis, Högskolan i Borås, Akademin för textil, teknik och ekonomi, 2017. http://urn.kb.se/resolve?urn=urn:nbn:se:hb:diva-13705.

Full text
Abstract:
Until approximately 50 years ago, wireless electronics was confined to military purposes. With the advancement of technology, consumer electronics found widespread applications in almost every aspect of our lives and numerous devices were developed using electromagnetic waves to transfer different types of data. In light of such advancements, the electromagnetic compatibility (EMC) evolved from a military concept to regulate the radio frequency requirements of the battlefield equipment to a mature and essential part in manufacturing and employing electronic devices. Medical devices were no exception and largely benefited from the ease of connectivity and mobility provided by usage of wireless electronics. Due to the sensitive nature of medical devices and extreme consequences of their malfunction, EMC grew to a centric issue in design and production of such devices. This work examines the electromagnetic compatibility of a wearable biomedical measurement system used for the assessment of mental stress of combatants in real time. This system was developed as a part of the ARTEC project and supported by the Spanish Ministry of Defense through the Future Combatant program [1]. We focus on the EMC of the electrocardiogram of the system and aim to identify its EMC requirements of this system while assessing it against various standards and protocols. Throughout this study, we elucidate the fundamentals of electromagnetic compatibility with specific attention to medical devices. Furthermore, we present our results after conducting several EMC tests to measure the compatibility of the electrocardiogram device using the Intertek guidelines. The emission test was performed while essential counter measures such as appropriate shielding and anti-interference filters had been applied.
APA, Harvard, Vancouver, ISO, and other styles
5

Chen, Chin-fu, and 陳進富. "A study on Certification System of Medical Device." Thesis, 2007. http://ndltd.ncl.edu.tw/handle/77750893445336418781.

Full text
Abstract:
碩士
義守大學
管理研究所碩士班
95
After the national health insurance put into practice, medical payment, government’s policy and enactment regarding health insurance are changed. It has influenced the medical structure, management and development of the medical device manufacturers. For example, all medical device manufacturers are required by Department of Health, Executive Yuan to gain the certification from GMP (Good Manufacturing Practices) due on June 20, 2005. In addition, foreign products need to apply for QSD (Quality System Documentation) from Department of Health. Without the certification of GMP and QSD, the foreign product is not allowed to sell the products in Taiwan. It is a manificated change for medical device manufacturers. This study, based on the concept of complex theory, applys the agent-based models incorporating the object orientation methodology, to investigate the relationship among the quality, behavior, and object of each agent. In this framework, agents interact with each other and the environement with policy changes. As a result, agent evolves and adapts in order to survive in the environement. The influence is related to behavior evolution between agents and the industry. The manufacturers can revise their behaviour and therefore reinforce and self-adjust from time to time. This study offers a new approach and insight into the medical device industry.
APA, Harvard, Vancouver, ISO, and other styles

Books on the topic "Medical devices certification"

1

United States. Government Accountability Office. Medical devices: Status of FDA's program for inspections by accredited organizations : report to Congressional committees. Washington, D.C: GAO, 2007.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
2

FDA medical device approval: Is there a better way? : hearing before the Subcommittee on Health Care, District of Columbia, Census, and the National Archives of the Committee on Oversight and Government Reform, House of Representatives, One Hundred Twelfth Congress, first session, June 2, 2011. Washington: U.S. G.P.O., 2011.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
3

W, Montgomery Ronald, Wood Kathryn J, and United States. Office of Aviation Medicine., eds. The applicability of commercial glare test devices in the aeromedical certification of pilot applicants. Washington, D.C: U.S. Dept. of Transportation, Federal Aviation Administration, Office of Aviation Medicine, 1994.

Find full text
APA, Harvard, Vancouver, ISO, and other styles

Book chapters on the topic "Medical devices certification"

1

Paganelli, Corrado, Marino Bindi, Laura Laffranchi, Domenico Dalessandri, Stefano Salgarello, Antonio Fiorentino, Giuseppe Vatri, and Arne Hensten. "Certification for Medical Devices." In Biomedical Devices, 161–82. Hoboken, NJ, USA: John Wiley & Sons, Inc., 2016. http://dx.doi.org/10.1002/9781119267034.ch7.

Full text
APA, Harvard, Vancouver, ISO, and other styles
2

Lawford, Mark, Tom Maibaum, and Alan Wassyng. "Certification of Software-Driven Medical Devices." In Lecture Notes in Computer Science, 293–95. Berlin, Heidelberg: Springer Berlin Heidelberg, 2010. http://dx.doi.org/10.1007/978-3-642-16561-0_29.

Full text
APA, Harvard, Vancouver, ISO, and other styles
3

Di Pietro, Licia, Carmelo De Maria, Andrés Díaz Lantada, Alice Ravizza, and Arti Ahluwalia. "Certification Pathways for Open-Source Medical Devices." In Engineering Open-Source Medical Devices, 127–44. Cham: Springer International Publishing, 2022. http://dx.doi.org/10.1007/978-3-030-79363-0_6.

Full text
APA, Harvard, Vancouver, ISO, and other styles
4

Rott, Peter. "Certification of Medical Devices: Lessons from the PIP Scandal." In Studies in European Economic Law and Regulation, 189–211. Cham: Springer International Publishing, 2019. http://dx.doi.org/10.1007/978-3-030-02499-4_9.

Full text
APA, Harvard, Vancouver, ISO, and other styles
5

Shaibun, Juliana. "Quality Assurance in Medical Devices." In Handbook of Research on Technology Applications for Effective Customer Engagement, 302–14. IGI Global, 2021. http://dx.doi.org/10.4018/978-1-7998-4772-4.ch019.

Full text
Abstract:
Quality management system (QMS) is acknowledged as the primary method for any manufacturer, especially medical device manufacturers, in order to sustain the product quality in the competitive advantage in business environment. QMS is an essential requirement for regulatory control in high risk medical devices. Globally, the number of medical device manufacturers certified by ISO 13485 is escalating. Ownership of this certification symbolizes the medical device manufacturer acquired high performance in their QMS. This bibliometric provides a brief review of the quality assurance and how safety plays an important role in medical devices. Bibliometric analysis guided user to summarize the essential part of quality assurance process in medical device. The insights presented in this research assist in building a firm theoretical base and direction for future research.
APA, Harvard, Vancouver, ISO, and other styles
6

Pianigiani, Silvia, and Tomaso Villa. "Biomechanical requirements for certification and quality in medical devices." In Human Orthopaedic Biomechanics, 501–14. Elsevier, 2022. http://dx.doi.org/10.1016/b978-0-12-824481-4.00005-6.

Full text
APA, Harvard, Vancouver, ISO, and other styles
7

Oliver, Anthony R. "Laboratory Quality Control and Accreditation." In Tutorial Topics in Infection for the Combined Infection Training Programme. Oxford University Press, 2019. http://dx.doi.org/10.1093/oso/9780198801740.003.0019.

Full text
Abstract:
According to the International Organization for Standardization (ISO), the ‘Medical laboratories—Requirements for quality and competence (ISO 15189:2012) BS EN ISO 15189:2012’ accreditation is defined as ‘a procedure by which an authoritative body gives formal recognition that an organization is competent to carry out specific tasks’. Accreditation is delivered by the ‘competent authority’ based on a set of defined standards and the continual internal audit of the laboratory processes and infrastructure against these standards to achieve conformance. Additionally, the ‘competent authority’ periodically undertakes assessments to ensure compliance with the standards. These assessments vary in frequency and nature depending upon the assessment body. In some instances (e.g. UK Accreditation Service, UKAS), the assessments are annual and based on a four- year cycle covering the whole laboratory repertoire and infrastructure. The HSE is responsible for the inspection and licencing of microbiological containment level 3 and 4 facilities. The HTA is responsible for legal registration of laboratories that process and store human tissue, and is mainly histology related. The MHRA provides guidelines on good laboratory practice, good clinical practice, good clinical laboratory practice, and good manufacturing practice, largely around clinical trial work. It is also responsible for accreditation of blood transfusion laboratories. Finally, it provides guidance on the In Vitro Diagnostic Medical Device Directive (IVDMDD, 98/ 79/ EC) and the regulation of medical ‘devices’ including diagnostic devices, where a ‘device’ is defined as including reagent kits and analytical platforms. EFI provides guidance and standards for transplantation and tissue typing laboratories across Europe. Until 2009, CPA provided accreditation for the majority of UK pathology services. CPA was acquired by the UK Accreditation Service in 2009. UKAS is a government- appointed national accreditation body for the UK that is responsible for certification, testing, inspection, and calibration services, and is the competent authority for all ISO standards, not just pathology. It covers various sectors, including healthcare, food production, energy supply, climate change, and personal safety. The majority of UK pathology services will be UKAS ISO15189 accredited by 2018, including transitional ‘dual’ CPA standards/ ISO15189 accreditation between 2015 and 2018. It also provides ISO22870:2006 accreditation that is point of care specific, as well as ISO17025:2005, which applies to calibration standards.
APA, Harvard, Vancouver, ISO, and other styles
8

"Clinical Practice Policy to Protect Children From Tobacco, Nicotine, and Tobacco Smoke." In eCigarettes, 38–47. American Academy of Pediatrics, 2017. http://dx.doi.org/10.1542/9781610022743-clinical.

Full text
Abstract:
Tobacco dependence starts in childhood. Tobacco exposure of children is common and causes illness and premature death in children and adults, with adverse effects starting in the womb. There is no safe level of tobacco smoke exposure. Pediatricians should screen for use of tobacco and other nicotine delivery devices and provide anticipatory guidance to prevent smoking initiation and reduce tobacco smoke exposure. Pediatricians need to be aware of the different nicotine delivery systems marketed and available. Parents and caregivers are important sources of children’s tobacco smoke exposure. Because tobacco dependence is a severe addiction, to protect children’s health, caregiver tobacco dependence treatment should be offered or referral for treatment should be provided (such as referral to the national smoker’s quitline at 1-800-QUIT-NOW). If the source of tobacco exposure cannot be eliminated, counseling about reducing exposure to children should be provided. Health care delivery systems should facilitate the effective prevention, identification, and treatment of tobacco dependence in children and adolescents, their parents, and other caregivers. Health care facilities should protect children from tobacco smoke exposure and tobacco promotion. Tobacco dependence prevention and treatment should be part of medical education, with knowledge assessed as part of board certification examinations.
APA, Harvard, Vancouver, ISO, and other styles
9

Hang Bob Yung, Ching, Lung Fung Tse, Wing Fung Edmond Yau, and Sze Yi Mak. "Additive Manufacturing in Customized Medical Device." In Advanced Additive Manufacturing [Working Title]. IntechOpen, 2021. http://dx.doi.org/10.5772/intechopen.101139.

Full text
Abstract:
The long-established application of rapid prototyping in additive manufacturing (AM) has inspired a revolution in the medical industry into a new era, in which the clinical-driven development of the customized medical device is enabled. This transformation could only be sustainable if clinical concerns could be well addressed. In this work, we propose a workflow that addresses critical clinical concerns such as translation from medical needs to product innovation, anatomical conformation and execution, and validation. This method has demonstrated outstanding advantages over the traditional manufacturing approach in terms of form, function, precision, and clinical flexibility. We further propose a protocol for the validation of biocompatibility, material, and mechanical properties. Finally, we lay out a roadmap for AM-driven customized medical device innovation based on our experiences in Hong Kong, addressing problems of certification, qualification, characterization of three dimensional (3D) printed implants according to medical demands.
APA, Harvard, Vancouver, ISO, and other styles

Conference papers on the topic "Medical devices certification"

1

Jepson, C. D. "The role of quality assurance certification in obtaining the CE mark for electromedical equipment." In Medical Devices Directive Digest of Papers. IEE, 1997. http://dx.doi.org/10.1049/ic:19971079.

Full text
APA, Harvard, Vancouver, ISO, and other styles
2

Rohloff, Kurt, Richard Schantz, Partha Pal, and Joseph Loyall. "Software Certification for Distributed, Adaptable Medical Systems: Position Paper on Challenges and Paths Forward." In 2007 Joint Workshop on High Confidence Medical Devices, Software, and Systems and Medical Device Plug-and-Play Interoperability (HCMDSS-MDPnP 2007). IEEE, 2007. http://dx.doi.org/10.1109/hcmdss-mdpnp.2007.5.

Full text
APA, Harvard, Vancouver, ISO, and other styles
3

Newton, D. "Case study in successful FDA 510(k) product certification." In IEE Seminar Exporting Medical Devices to the USA: A Practical Guide to the FDA Regulations. IEE, 1998. http://dx.doi.org/10.1049/ic:19980992.

Full text
APA, Harvard, Vancouver, ISO, and other styles
4

Dey, Animesh, and Robert Tryon. "Confidence Estimates due to Uncertainty in Multi-Disciplinary Computational Analysis." In ASME 2013 Conference on Frontiers in Medical Devices: Applications of Computer Modeling and Simulation. American Society of Mechanical Engineers, 2013. http://dx.doi.org/10.1115/fmd2013-16036.

Full text
Abstract:
Simulation-based design and certification is fundamentally about making decisions with uncertainty. However, minimizing uncertainty comes at a price — more testing to better define the variability in input parameters, higher fidelity analyses at a finer scale to limit the uncertainty in the physics, etc. Variability in each input parameter does not affect the uncertainty in the system response equally. Nor does every model refinement reduce the uncertainty in the system response. This paper presents a computational methodology that estimates the sensitivity of uncertainty in input variables and the sensitivity of modeling approximations to the final output. In the current age of large multi-disciplinary virtual simulation, this is useful in determining how to minimize overall uncertainty in analytical predictions. In addition, the methodology can be used to optimize for the best use of computational and testing resources to arrive at most robust predictions.
APA, Harvard, Vancouver, ISO, and other styles
5

Tryon, Robert G., Animesh Dey, Richard A. Holmes, and Ganapathi Krishnan. "Computational Models to Predict the Structural Reliability of Aerospace Systems." In ASME 2013 Conference on Frontiers in Medical Devices: Applications of Computer Modeling and Simulation. American Society of Mechanical Engineers, 2013. http://dx.doi.org/10.1115/fmd2013-16090.

Full text
Abstract:
Three case studies are presented in which computational-based methodologies have been used to assess structural reliability in the aerospace industry. The studies involve hot section turbine disks of a helicopter engine, fan blades of a commercial airline engine and bearings in an auxiliary power unit. In all cases, the results of the computational models were used to support the certification process for design and application changes. The statistical variation in design and usage parameters including geometry, materials, speed, temperature and other environmental factors are considered. The response surface approach was used to construct a durability performance function. This performance function is used with the first order reliability method (FORM) to determine the probability of failure and the sensitivity of the failure to the design and usage parameters. A hybrid combination of perturbation analysis and Monte Carlo simulation is used to incorporate time dependent random variables. System reliability is used to determine the system probability of failure, and the sensitivity of the system durability to the design and usage parameters.
APA, Harvard, Vancouver, ISO, and other styles
6

Hrgarek, Nadica. "Certification and regulatory challenges in medical device software development." In 2012 4th International Workshop on Software Engineering in Health Care (SEHC). IEEE, 2012. http://dx.doi.org/10.1109/sehc.2012.6227011.

Full text
APA, Harvard, Vancouver, ISO, and other styles
7

Sezdi, Mana, and Nazif Ilker Sezdi. "Certification of medical device test, control and calibration service providers." In 2017 Medical Technologies National Congress (TIPTEKNO). IEEE, 2017. http://dx.doi.org/10.1109/tiptekno.2017.8238119.

Full text
APA, Harvard, Vancouver, ISO, and other styles
8

Sobrinho, Alvaro, Angelo Perkusich, Leandro Dias da Silva, Thiago Cordeiro, Joilson Rego, and Paulo Cunha. "Towards medical device certification: A colored Petri Nets model of a surface electrocardiography device." In IECON 2014 - 40th Annual Conference of the IEEE Industrial Electronics Society. IEEE, 2014. http://dx.doi.org/10.1109/iecon.2014.7048879.

Full text
APA, Harvard, Vancouver, ISO, and other styles
9

Turculeţ, Alina. "From Pedagogy to Politeness: Aspects Regarding Feedback in Online Learning Context." In World Lumen Congress 2021, May 26-30, 2021, Iasi, Romania. LUMEN Publishing House, 2022. http://dx.doi.org/10.18662/wlc2021/69.

Full text
Abstract:
The online learning environment has challenged the educational relationships over the last years. The medical safety has hidden us behind some monitors, devices or platforms that allowed us to continue our studies and our professional activities. From faces with or without associated names, we turned into names that accompany empty icons on the wall. Most often, we had to keep our cameras off. When we turned them on and shared our faces with the audience, we offered and received feedback much easier. The feedback has an important role in any human communication. More than that, in the educational field, the feedback contributes to the adjustments of the teaching – learning – evaluating process. On the positive side, the teacher gives feedback in order to reinforce the appropriate learning behaviour of the student and the student offers feedback to ensure the proper adjustment of the teaching behaviour. The pattern of giving and receiving feedback is simple and visible in all face-to-face communication that develops an educational activity. What happens in the online mediated education? What happens when faces see no faces? Our study investigates the feedback from the perspective of the online mediated educational relationships. Thus, we analyzed the responses of the students to some seminar tasks regarding the use of educational platforms and the role of feedback in the learning process. The target population consisted in 135 students enrolled in the certification program for teaching career. Our findings show that feedback as reinforcement communicative behaviour upgrades the politeness strategy and feedback as a pedagogical principle helps to replace the missing face-to-face interaction in online mediated learning.
APA, Harvard, Vancouver, ISO, and other styles
10

Wu, Yuebin, Nigel N. Clark, and Daniel K. Carder. "Effects of CVS Tunnel, Ambient and Instrument Dilution on Characteristics of Nano Diesel Particulate Matter Evolution." In ASME 2012 Internal Combustion Engine Division Fall Technical Conference. American Society of Mechanical Engineers, 2012. http://dx.doi.org/10.1115/icef2012-92105.

Full text
Abstract:
In 2007, U.S. certification standards for heavy duty on-road diesel engine particulate matter (PM) emissions were reduced from 0.1g/bhp-hr to 0.01g/bhp-hr, representing an order of magnitude reduction in pollutant level. The Tier 4 standards for nonroad diesel engines, being phased in from 2008 through 2015, also require similar level of reduction in PM. Most conventional diesel engines could meet these low PM standards, once equipped with a diesel particulate filter (DPF). However, accurate, repeatable measurements of this PM may pose significant challenges. Gravimetric PM measurement involves diluting exhaust, then collecting the resultant aerosol sample on approved filter media. Few data exist to characterize the evolution of particulate matter (PM) in dilution tunnels, particularly at very low PM mass levels. Data are lacking as well, for PM evolution in portable dilution instruments and in exhaust plumes downstream of the tailpipe. Size distributions of ultra-fine particles in the diesel exhaust from a naturally aspirated ISUZU C240 diesel engine, equipped with a DPF, were studied. Particle size distribution data, during steady-state engine operations, were collected using a Cambustion DMS500 Fast Particulate Spectrometer. The effects of dilution ratios, dilution rates, and residence times on the diesel particulate matter (DPM) size distributions were analyzed and discussed. Measurements were made for three dilution methods: dilution in standard primary and secondary-dilution tunnels with a full scale Constant Volume Sampler (CVS) system, instrument dilution with a Portable Particulate Measurement Device (PPMD), and ambient dilution at the post-tailpipe exhaust plume centerline. Gaseous emissions measurements were utilized as surrogate confirmation of adequate mixing at the various measurement locations, as well as an indicator of dilution ratios. Tunnel sample results indicated varying size distributions at tunnel cross sections where the flow was still developing. Evolution of particle-size distributions was observed even for fully mixed primary flow conditions. Size distributions at the end of the secondary dilution tunnel were observed to vary with different secondary-dilution ratios. Particle-size distributions of post-tailpipe and PPMD test results were analyzed and compared with those results collected from the full-flow tunnel. Results from post-tailpipe sampling indicate that nucleation was the dominant process when the exhaust plume was diluted along the post-tailpipe centerline. Results from PPMD dilution measurements indicate that change of particle-size-distribution curves, including number count and mass concentration levels, were not as strongly correlated to dilution ratios as were the results from the other two sampling methods. This study shows that particle-size distributions measured inside full-flow dilution tunnel can adequately mimic freshly emitted exhaust sampled immediately post-tailpipe.
APA, Harvard, Vancouver, ISO, and other styles
You might also be interested in the extended bibliographies on the topic 'Medical devices certification' for particular source types:
Journal articles
We offer discounts on all premium plans for authors whose works are included in thematic literature selections. Contact us to get a unique promo code!

To the bibliography