Relevant bibliographies by topics / Medical device validation

Contents

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

Academic literature on the topic 'Medical device validation'

Author: Grafiati
Published: 28 June 2021
Last updated: 8 February 2022

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Journal articles on the topic "Medical device validation"

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Klein, Devorah E., and Matthew J. Jordan. "Methods of Assessing Medical Devices." Proceedings of the Human Factors and Ergonomics Society Annual Meeting 46, no. 23 (September 2002): 1890–94. http://dx.doi.org/10.1177/154193120204602305.

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While designing and validating any complex system has challenges, the medical domain has specific requirements which must be considered for a system or device to be successful. The environments, communities of use, and interactions are varied, unpredictable, uncontrolled, and ever-changing. Given the environments, communities of use, and interactions involved with medical devices, successful early and late validation of the device must be informed by the context of use itself. Building “frameworks” which represent the context of use for the device can focus validation goals, methods, and criteria and ensure that validation is directed and appropriate. In this paper we present a process and associated methods for defining the frameworks in which medical devices can be successfully assessed. The phases of the process include Phase1: Definition in which a framework of understanding is built which represents the environment of use, community of users, and the interactions between systems and users for the medical device in development. In Phase 2: Validation the framework which defines the environment of use, community of users, and the interactions between systems and users is used to develop a validation approach and criteria. The developing device is then validated against the framework itself.
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Jones, Randy D., David L. Stalling, Jon Davis, Patrick Jurkovich, and Kirk LaPointe. "Software validation for medical device manufacturing." Quality Assurance Journal 7, no. 4 (2003): 242–47. http://dx.doi.org/10.1002/qaj.245.

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Gagliardi, John. "Medical Device Software: Verification, Validation and Compliance." Biomedical Instrumentation & Technology 45, no. 2 (March 1, 2011): 95. http://dx.doi.org/10.2345/0899-8205-45.2.95.

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Desain, C., and C. Vercimak Sutton. "Validation for Medical Device and Diagnostic Manufacturers." Journal of Clinical Engineering 21, no. 1 (January 1996): 30–31. http://dx.doi.org/10.1097/00004669-199601000-00010.

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標準委員会. "Guideline for Steilization of Medical Device Validation." JAPANES JOURNAL OF MEDICAL INSTRUMENTATION 68, no. 9 (September 1, 1998): 399–406. http://dx.doi.org/10.4286/ikakikaigaku.68.9_399.

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標準委員会. "Guideline for Sterilization of Medical Device Validation." JAPANES JOURNAL OF MEDICAL INSTRUMENTATION 68, no. 7 (July 1, 1998): 295–311. http://dx.doi.org/10.4286/ikakikaigaku.68.7_295.

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Zhao, Yincheng, Kuangjie Sheng, Zheng Wang, Xilin Zhang, HengyiYang, and Rui Miao. "Process Validation and Revalidation in Medical Device Production." Procedia Engineering 174 (2017): 686–92. http://dx.doi.org/10.1016/j.proeng.2017.01.207.

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McEvoy, Brian, Stacy Bohl Wiehle, Ken Gordon, Gerry Kearns, Paulo Laranjeira, and Nicole McLees. "Advancing the Sustainable Use of Ethylene Oxide through Process Validation." Biomedical Instrumentation & Technology 55, s3 (March 1, 2021): 35–44. http://dx.doi.org/10.2345/0899-8205-55.s3.35.

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Abstract Based on excellent material compatibility and ability for scale, ethylene oxide (EO) sterilization constitutes approximately 50% of single-use medical device sterilization globally. Epidemiological considerations have elevated focus toward optimization of EO processes, whereby only necessary amounts of sterilant are used in routine processing. EO sterilization of medical devices is validated in accordance with AAMI/ANSI/ISO 11135:2014 via a manner in which a sterility assurance level (SAL) of 10−6 is typically achieved, with multiple layers of conservativeness delivered, using “overkill” approaches to validation. Various optimization strategies are being used throughout the medical device industry to deliver the required SAL while utilizing only necessary amounts of sterilant. This article presents relevant experiences and describes challenges and considerations encountered in delivering EO process optimization. Thus far, the results observed by the authors are encouraging in demonstrating how EO processing can be optimized in the delivery of critical single-use medical devices for patient care.
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Clark, Shannon E. "Training Decay Selection for Usability Validation." Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care 5, no. 1 (June 2016): 76–83. http://dx.doi.org/10.1177/2327857916051018.

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When conducting usability validation testing, representative users must use the device in the expected conditions of use in the field. There is usually a period of time—days or weeks—between the point in time a user is trained, and the moment they use the device for the first time. For this reason, the FDA acknowledges the need for “training decay” as part of usability validation testing, but manufacturers face challenges simulating real-time decays. In response to challenges associated with lags of days or weeks between training and usability validation testing, medical device manufacturers typically simulate shortened training decay periods. This paper discusses the theory behind the shapes of various training decay curves and the variables that drive differences between training decay curves. The author proposes to use a task-based approach for defining training decay curves in usability validation studies and sets out generalized training decay curves at a high level. Future research could reveal detailed and generalizable training decay curves. Identifying generalizable training decay curves could standardize the usability testing required for medical devices, and ultimately improve use error identification while avoiding an undue toll on manufacturer resources.
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Vogel, David A. "Medical Device Validation: How Vendors Can Assist their Customers." Biomedical Instrumentation & Technology 41, no. 6 (November 2007): 465–68. http://dx.doi.org/10.2345/0899-8205(2007)41[465:mdvhvc]2.0.co;2.

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Dissertations / Theses on the topic "Medical device validation"

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Kothari, Ashish (Ashish Shrikant). "Impact of the CE mark approval on exit opportunities and validation for early stage medical device companies." Thesis, Massachusetts Institute of Technology, 2011. http://hdl.handle.net/1721.1/65522.

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Thesis (S.M.)--Harvard-MIT Division of Health Sciences and Technology, 2011.
Cataloged from PDF version of thesis.
Includes bibliographical references (p. 85-87).
The aim of this thesis was to look at the impact of acquiring the CE marking approval on the outcome of early stage medical device companies, specifically its impact on strategic acquisition opportunities and on valuation. We gathered data on acquisitions of 237 companies over the past ten years, from April 01, 2002 to March 31, 2011. These data were gathered from various sources, and information on the date of acquisition, enterprise value, funds invested to date, date of incorporation, status and dates of CE and FDA approvals, patent status, type of regulatory clearances (PMA versus 510K), type of sales models (direct versus distributorship), capitalization status and last twelve month stock returns of the acquirer was acquired. These data were then analyzed using basic statistical methods and multivariate linear regression analyses to determine the significance of the CE marking on the outcomes of these companies. Our results support the claim that the CE mark does significantly improve outcomes for early stage medical device companies, in terms of time to strategic acquisition, which is by far the commonest exit route for these companies. On the other hand, we did not find any statistically significant impact of acquisition of the CE mark on the valuation or valuation multiples of these companies. These results have potential implications for management of these early stage medical device companies in making strategic decisions and for investors who are concerned about the exit opportunities and valuations, especially as it relates to funds invested. There could also be some policy implications in terms of the effort, duration and cost of getting a CE approval versus that of an FDA approval, which is especially important given the current growing concern about increasingly stringent regulation, rising costs and increasing delays in FDA approvals for medical devices.
by Ashish Kothari.
S.M.
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Guynes, Eric C. "Strategies for Shipping Temperature-Sensitive Medical Devices Using Cognitive Mapping." ScholarWorks, 2018. https://scholarworks.waldenu.edu/dissertations/5872.

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Supply chain management (SCM) practitioners who ship temperature-sensitive diagnostic medical devices (DMDs) to clinicians must use effective cold chain management (CCM) strategies to avoid temperature excursions that contribute to medical device errors. Such errors have caused patient harm and death, which costs the U.S. health care system billions of dollars per year. The purpose of this qualitative multiple case study was to explore strategies for selecting and managing cold chain shipping solutions (CCSSs) requiring SCM executives to trade cost for regulatory compliance and predictability when mitigating temperature variations that occur during shipping. The conceptual framework for the study was the 6-change approaches, and its underpinnings that framed the exploration into the strategies some medical device executives use for shipping temperature-sensitive DMD tests and controls. Data were collected from in-depth interviews, field notes, and existing literature. The target population was 3 SCM executives working in California, New Jersey, and Ireland with at least 5 years of CCM experience in the medical device industry. A purposive sampling procedure guided the selection of participants for in-depth interviews. The data analysis included pattern matching techniques, central analysis, and collapse analysis. The results of this study indicated 3 successful strategies: validation of CCSSs, compliant shipping of DMDs, and CCM best practices. The study was socially significant because the findings may prevent medical device failures that have caused U.S. Food and Drug Administration recalls and patient harm.
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Munkhammar, Tobias. "Ground Reaction Force Prediction during Weighted Leg Press and Weighted Squat in a Flywheel Exercise Device." Thesis, KTH, Skolan för teknik och hälsa (STH), 2017. http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-211194.

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When performing a biomechanical analysis of human movement, knowledge about the ground reaction force (GRF) is necessary to compute forces and moments within joints. This is important when analysing a movement and its effect on the human body. To obtain knowledge about the GRF, the gold standard is to use force plates which directly measure all three components of the GRF (mediolateral, anteroposterior and normal). However, force plates are heavy, clunky and expensive, setting constraints on possible experimental setups, which make it desirable to exclude them and instead use a predictive method to obtain the full GRF. Several predictive methods exist. The node model is a GRF predictive method included in a musculoskeletal modeling software. The tool use motion capture and virtual actuators to predict all three GRF components. However, this model has not yet been validated during weighted leg press and weighted squat. Furthermore, the normal component of the GRF can be measured continuously during the activity with pressure sensitive insoles (PSIs), which might provide better accuracy of the GRF prediction. The objectives of this thesis were to investigate whether force plates can be exluded during weighted leg press and weighted squat and to investigate whether PSIs can improve the GRF prediction. To investigate this, the node model and a developed shear model was validated. The shear model computes the two shear GRF components based on data from PSIs, an external load acting upon the body and data from a motion capture system. Both the node model and the shear model were analysed with two test subjects performing two successive repetitions of both weighted squat and weighted leg press in a flywheel exercise device. During the leg press exercise, the node model had a mean coeffcient of correlation (Pearson's) ranging from 0.70 to 0.98 for all three directions with a mean root mean square error ranging between 8 % to 20 % of the test person's body weight. The developed shear model had a coeffcient of correlation (Pearson's) between 0.64 to 0.99 and a mean root mean square error between 3 % and 21 % of the test person's body weight. This indicates that it is possible to exclude force plates and instead predict the GRF during weighted leg press. During squat, neither the node model nor the shear model provided accurate results regarding the mediolateral and anteroposterior components of the GRF, suggesting that force plates can not yet be excluded to obtain the full GRF during weighted squat. The results of the normal component during leg press was somewhat improved with the shear model compared to the node model, indicating that using PSIs can improve the results to some extent.
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Hidegová, Simona. "Validace multikanálové bioimpedance cév za použití synchronizované cévní sonografie." Master's thesis, Vysoké učení technické v Brně. Fakulta elektrotechniky a komunikačních technologií, 2021. http://www.nusl.cz/ntk/nusl-442505.

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The inclusion of a new device in clinical practice requires an adequate validation. The original publication which introduced multichannel bioimpedance monitor MBM was focused on discribing its technical parameters and demonstration measurements. Further evaluation desires comparision with other standard measuring device. This thesis describes pulse wave measurement by MBM and by other medical devices used for establishing cardiovascular risk. It proposes the validation experiment with synchronized vascular ultrasonography as a reference method. The process of the experimental measurement, aquired data and following data analysis are described in detail. The outputs of the experiment are statistically evaluated. The MBM’s performance and design of the experiment are discussed.
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Alexander, K. L. "Design for validation of medical devices and equipment." Thesis, University of Cambridge, 1998. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.595422.

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Design for validation is aimed at designing medical devices to make them easier and more economic to validate. Changes to the medical device regulations within the past few years have forced the industry to focus attention on design and validation in order to ensure that a device and its associated manufacturing and test equipment are reliable and fit for purpose. In order for this to happen, design must affect validation and validation must affect design. However, current guidance on validation as it applies to design is inadequate and, as a result, validation is generally not well understood amongst medical device designers. The goal of design for validation is to provide guidance in order to help designers achieve integrated design, development and validation. It forms part of a wider definition of Good Design Practice which aims to encourage fitness for purpose within commercial reality. Exploratory research was carried out in the form of studying ideal practice and current practice in order to identify the factors which contribute to integrated design, development and validation. Case studies were analysed, a model of ideal practice was developed and interviews were carried out with various medical device designers and project managers. From the information gathered, two basic designer needs were identified which had to be fulfilled in order for designers to integrate design, development and validation. A practical approach to design for validation was formulated in order to address the two designer needs through the use of a model of design for validation and a series of six design tactics. The approach was evaluated by sending questionnaires to industry. The feedback was very positive and, based on the evaluation, revisions were made to the design for validation model and design tactics. The revisions will be carried forward to the next phase of the research which is the development of a Design for Validation Workbook.
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Andriani, Rudy Thomas. "Design and Validation of Medical Devices for Photothermally Augmented Treatments." Thesis, Virginia Tech, 2014. http://hdl.handle.net/10919/50503.

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*1-Dimensional Advective-Diffusion Model in Porous Media Infusion of therapeutic agents into tissue is makes use of two mass transport modes: advective transport, and molecular diffusion. Bulk infusion into a 0.6% wt agarose phantom was modeled as an infinite, homogenous, and isotropic porous medium saturated with the same solvent used in the infused dye tracer. The source is assumed to be spherical and isotropic with constant flow rate and concentration. The Peclet numberdecreases with power function Pe = 15762t0.337 due to the decrease in mean dye-front pore velocity as V goes to Vfinal. Diffusive mass transport does not become significant during any relevent time period. *Arborizing Fiberoptic Microneedle Catheter We have developed an arborizing catheter that allows multiple slender fused-silica CED cannulae to be deployed within a target volume of the brain via a single needle tract, and tested it in a widely accepted tissue phantom. The arborizing catheter was constructed by bonding and encapsulating seven slender PEEK tubes in a radially symmetric bundle with a progressive helical angle along the length, then grinding a conicle tip where the helical angle is greatest. The catheter was tested by casting 0.6% wt agarose around the device with all needles deployed to a tip-to-tip distance of 4 mm. Phantom temperature was maintained at 26 ± 2°C. 5% wt Indigo Carmine dye was infused at a rate of 0.3 uL/min/needle for 4 hours. N=4 infusions showed a Vd/Vi of 139.774, with a standard deviation of 45.01. This is an order of magnitude greater than single-needle infusions under similar conditions [45]. The arborizer showed the additional benefit of arresting reflux propagating up the lengths of individual needles, which has historically been a weakness of single-needle CED catheter designs. *In Vivo Co-Delivery of Single Walled Carbon Nano-horns and Laser Light to Treat Human Transitional Cell Carcinoma of the Urinary Bladder in a Rodent Model Using a rodent model we explored a treatment method for Transitional Cell Carcinoma (TCC) in the urinary bladder in which Single Walled Carbon Nanohorn (SWNH) solution and 1064 nm laser light are delivered into tumorous tissue via a co-delivery Fiberoptic Microneedle Device (FMD). Preliminary treatment parameters were determined by injecting SWNH solutions with concentrations of 0 mg/mL, 0.17 mg/mL, or 0.255 mg/mL into ex vivo porcine skin and irradiating each for three minutes at laser powers of 500 mW, or 1000 mW. The combination with the greatest temperature increase without burning the tissue, 0.17 mg/mL at 1000 mW, was selected for the in vivo treatment. TCC tumors were induced in a rodent model by injecting a solution of 106 AY27 urothelial carcinoma cells into the lateral aspect of the left hind leg of young, female F344 rats. When tumors reached 5-10 mm3, rats were anesthitized and treated. SWNH solution was injected directly into the tumor and irradiated until the target temperature of 60degC was achieved. The rats were then recovered from anestesia and monitored for 7-14 days, at which point they were humanely sacrificed, and the tumors prepared for histological examination. Histological assessment of areas of FMD treatment correlated well with gross morphological appearance. Foci of tumor necrosis showed sharp (1-2 mm) delineation from areas of viable tumor (not treated) and normal tissue. We believe we have demonstrated the feasibility of using the FMD for treatment of urothelial carcinoma using an animal model of this disease, and are encouraged to continue development of this treatment and testing in larger animal models.
Master of Science
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Cruz, Vítor Pedro Tedim Ramos. "New tools for cognitive and motor rehabilitation: development and clinical validation." Doctoral thesis, Universidade de Aveiro, 2014. http://hdl.handle.net/10773/15775.

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Doutoramento em Ciências e Tecnologias da Saúde
Nervous system disorders are associated with cognitive and motor deficits, and are responsible for the highest disability rates and global burden of disease. Their recovery paths are vulnerable and dependent on the effective combination of plastic brain tissue properties, with complex, lengthy and expensive neurorehabilitation programs. This work explores two lines of research, envisioning sustainable solutions to improve treatment of cognitive and motor deficits. Both projects were developed in parallel and shared a new sensible approach, where low-cost technologies were integrated with common clinical operative procedures. The aim was to achieve more intensive treatments under specialized monitoring, improve clinical decision-making and increase access to healthcare. The first project (articles I – III) concerned the development and evaluation of a web-based cognitive training platform (COGWEB), suitable for intensive use, either at home or at institutions, and across a wide spectrum of ages and diseases that impair cognitive functioning. It was tested for usability in a memory clinic setting and implemented in a collaborative network, comprising 41 centers and 60 professionals. An adherence and intensity study revealed a compliance of 82.8% at six months and an average of six hours/week of continued online cognitive training activities. The second project (articles IV – VI) was designed to create and validate an intelligent rehabilitation device to administer proprioceptive stimuli on the hemiparetic side of stroke patients while performing ambulatory movement characterization (SWORD). Targeted vibratory stimulation was found to be well tolerated and an automatic motor characterization system retrieved results comparable to the first items of the Wolf Motor Function Test. The global system was tested in a randomized placebo controlled trial to assess its impact on a common motor rehabilitation task in a relevant clinical environment (early post-stroke). The number of correct movements on a hand-to-mouth task was increased by an average of 7.2/minute while the probability to perform an error decreased from 1:3 to 1:9. Neurorehabilitation and neuroplasticity are shifting to more neuroscience driven approaches. Simultaneously, their final utility for patients and society is largely dependent on the development of more effective technologies that facilitate the dissemination of knowledge produced during the process. The results attained through this work represent a step forward in that direction. Their impact on the quality of rehabilitation services and public health is discussed according to clinical, technological and organizational perspectives. Such a process of thinking and oriented speculation has led to the debate of subsequent hypotheses, already being explored in novel research paths.
As doenças do sistema nervoso estão associadas a défices cognitivos e motores, sendo responsáveis pelas maiores taxas de incapacidade e impacto global. A sua recuperação é difícil e depende em simultâneo da plasticidade cerebral e de programas de neurorreabilitação complexos, longos e dispendiosos. Este trabalho explora duas linhas de investigação, que visam soluções sustentáveis para melhoria do tratamento de défices cognitivos e motores. Ambos os projetos foram desenvolvidos em paralelo, partilhando uma abordagem assisada onde se combinam tecnologias de baixo custo com processos clínicos comuns. O objetivo era obter tratamentos mais intensivos e supervisionados, melhorar o processo de decisão clínica e eliminar barreiras no acesso aos cuidados de saúde. O primeiro projeto (artigos I – III) permitiu o desenvolvimento e avaliação de uma plataforma online para treino cognitivo (COGWEB), adequada para uso intensivo, em casa ou instituições, e num largo espectro de idades e doenças com envolvimento das funções cognitivas. A sua usabilidade foi testada numa consulta de memória, sendo de seguida implementada numa rede colaborativa que envolveu 41 centros e 60 profissionais. A taxa de adesão aos planos de treino cognitivo online foi 82,8% aos 6 meses, verificando-se uma intensidade média de 6 horas/semana. O segundo projeto (artigos IV – VI) originou a construção e validação de um dispositivo de reabilitação inteligente para doentes com acidente vascular cerebral (AVC). Permite estímulos proprioceptivos no lado hemiparético, enquanto caracteriza o movimento tridimensional em ambulatório (SWORD). A estimulação vibratória foi bem tolerada pelos doentes e um sistema automático de caracterização motora revelou resultados comparáveis aos de uma escala utilizada frequentemente na prática clínica. O sistema integrado foi testado num ensaio clínico randomizado e controlado com placebo para avaliação do impacto numa tarefa de reabilitação motora na fase subaguda após AVC. O número de movimentos correctos numa tarefa mão-boca aumentou em média 7,2/minuto, enquanto a probabilidade de ocorrência de erro se reduziu de 1:3 para 1:9. A neurorreabilitação e a neuroplasticidade têm incorporado abordagens de múltiplos domínios das neurociências. Em simultâneo, a sua utilidade para os doentes e sociedade está dependente do desenvolvimento de tecnologias mais eficazes que facilitem também a disseminação do conhecimento entretanto produzido. Os resultados obtidos através do presente trabalho representam um passo adicional nessa direcção. O seu impacto na qualidade dos serviços de reabilitação e saúde pública são discutidos segundo perspectivas clínica, tecnológica e organizacional. Este processo de reflexão foi gerador de novas hipóteses, algumas já em exploração através de linhas de investigação específicas.
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Hsieh, Uiong-Zoei, and 謝泳叡. "The Verification and Validation of Software Contained in the Medical Devices: The Example of Cephalometric Analysis System." Thesis, 2008. http://ndltd.ncl.edu.tw/handle/38902362699493364479.

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碩士
南台科技大學
電機工程系
96
The failures of medical device might cause hazard to patients or operators. So, the software contained in a medical device should be verified and validated to insure the safety and the quality. Software engineering practices, risk analysis and management, and configuration management should be integrated in the study of software verification and validation (SV&V). Those approaches are acceptable by the FDA for the SV&V. In this work, the V-model was introduced in the software development process for the quality management of software development. The fault tree analysis (FTA) techniques were applied in the procedure of risk analysis and management for the SV&V. All of the procedures should be integrated in the so called “configuration management”. The procedures of SV&V for the developing “Cephalometric Analysis system” (CEPH) and its related works, such as software developed model, requirements specification, design specification, software test, SV&V and risk managements are also presented in the study. Finally, the documents developed in this study are hoped that to be agreeable with FDA’s conditions for the content of premarket submissions of software contained in a medical device.
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Books on the topic "Medical device validation"

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Vercimak, Sutton Charmaine, ed. Validation for medical device and diagnostic manufacturers. 2nd ed. Buffalo Grove, Ill: Interpharm Press, 1998.

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Medical device software verification, validation and compliance. Norwood, Mass: Artech House, 2011.

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Vercimak, Sutton Charmaine, ed. Validation for medical device and diagnostic manufacturers. 2nd ed. Buffalo Grove, IL: Interpharm Press, 1994.

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Haider, Syed Imtiaz. Validation standard operating procedures: A step-by-step guide for achieving compliance in the pharmaceutical, medical device, and biotech industries. 2nd ed. Boca Raton: Taylor & Francis, 2006.

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Dills, David. Technical guide: Conducting effective medical device validations. Royal Palm Beach, FL: Institute of Validation Technology, 1999.

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Dills, David. Technical guide: Conducting effective medical device validations. Royal Palm Beach, FL: Institute of Validation Technology, 1999.

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Lopez, Orlando. Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation. Boca Raton : Taylor & Francis, [2018]: Productivity Press, 2018. http://dx.doi.org/10.4324/9781315174617.

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The Medical Device Validation Handbook, Second Edition. Regulatory Affairs Professionals Society (RAPS), 2018.

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Pharmaceutical and Medical Device Validation by Experimental Design. Informa Healthcare, 2007.

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Torbeck, Lynn D., ed. Pharmaceutical and Medical Device Validation by Experimental Design. CRC Press, 2007. http://dx.doi.org/10.3109/9781420055702.

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Book chapters on the topic "Medical device validation"

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Sivakumar, M. S., Valentine Casey, Fergal McCaffery, and Gerry Coleman. "Improving Verification & Validation in the Medical Device Domain." In Systems, Software and Service Process Improvement, 61–71. Berlin, Heidelberg: Springer Berlin Heidelberg, 2011. http://dx.doi.org/10.1007/978-3-642-22206-1_6.

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Brewer, Rebecca. "Cleaning Validation for the Pharmaceutical, Biopharmaceutical, Cosmetic, Nutraceutical, Medical Device and Diagnostic Industries." In Handbook of Validation in Pharmaceutical Processes, 711–47. 4th ed. Boca Raton: CRC Press, 2021. http://dx.doi.org/10.1201/9781003163138-45.

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Schönberger, Marius, and Tatjana Vasiljeva. "How Computer System Validation Contributes to Performance Improvements for Medical Device Manufactures: The Case of Latvian SME." In Lecture Notes in Networks and Systems, 595–610. Cham: Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-030-44610-9_58.

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Leucker, Martin, Malte Schmitz, and Danilo à Tellinghusen. "Runtime Verification for Interconnected Medical Devices." In Leveraging Applications of Formal Methods, Verification and Validation: Discussion, Dissemination, Applications, 380–87. Cham: Springer International Publishing, 2016. http://dx.doi.org/10.1007/978-3-319-47169-3_29.

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Leucker, Martin. "Challenges for the Dynamic Interconnection of Medical Devices." In Leveraging Applications of Formal Methods, Verification and Validation. Specialized Techniques and Applications, 387–90. Berlin, Heidelberg: Springer Berlin Heidelberg, 2014. http://dx.doi.org/10.1007/978-3-662-45231-8_29.

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Grosu, Radu, Elizabeth Cherry, Edmund M. Clarke, Rance Cleaveland, Sanjay Dixit, Flavio H. Fenton, Sicun Gao, et al. "Compositional, Approximate, and Quantitative Reasoning for Medical Cyber-Physical Systems with Application to Patient-Specific Cardiac Dynamics and Devices." In Leveraging Applications of Formal Methods, Verification and Validation. Specialized Techniques and Applications, 356–64. Berlin, Heidelberg: Springer Berlin Heidelberg, 2014. http://dx.doi.org/10.1007/978-3-662-45231-8_26.

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Ogrodnik, Peter J. "Evaluation (Validation and Verification)." In Medical Device Design, 201–53. Elsevier, 2013. http://dx.doi.org/10.1016/b978-0-12-391942-7.00009-x.

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Ogrodnik, Peter. "Evaluation (validation and verification)." In Medical Device Design, 317–75. Elsevier, 2020. http://dx.doi.org/10.1016/b978-0-12-814962-1.00010-7.

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"Preventing Recalls during Production Validation." In Preventing Medical Device Recalls, 98–109. CRC Press, 2014. http://dx.doi.org/10.1201/b17210-11.

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Eagles, Sherman. "Software Verification and Validation." In Handbook of Medical Device Design, 601–27. CRC Press, 2019. http://dx.doi.org/10.1201/9780429285141-24.

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Conference papers on the topic "Medical device validation"

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Jiang, Zhihao, Miroslav Pajic, Allison Connolly, Sanjay Dixit, and Rahul Mangharam. "A platform for implantable medical device validation." In Wireless Health 2010. New York, New York, USA: ACM Press, 2010. http://dx.doi.org/10.1145/1921081.1921115.

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Pajic, Miroslav, Zhihao Jiang, Allison Connolly, Sanjay Dixit, and Rahul Mangharam. "A platform for implantable medical device validation." In the 9th ACM/IEEE International Conference. New York, New York, USA: ACM Press, 2010. http://dx.doi.org/10.1145/1791212.1791284.

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Zhang, Bolun, Daniel Farley, Heidi-Lynn Ploeg, and Michael Zinn. "Validation of Feedback Control Approach for an Implantable Limb Lengthening Device." In 2017 Design of Medical Devices Conference. American Society of Mechanical Engineers, 2017. http://dx.doi.org/10.1115/dmd2017-3456.

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Lower limb length discrepancy (LLD), defined by unequal length of paired lower limbs, contributes to lower back pain, osteoarthritis of the hip, and stress fractures [1–3]. The Center for Disease Control and Prevention estimated that there were approximately 700 children born with LLD each year in US [4]. Patients may receive distraction osteogenesis treatment, in which an osteotomy is performed on the shorter limb, and mechanical force is applied to gradually distract the two halves of the bone during the healing process. This stretches the bone callus during healing to achieve desired limb length upon callus consolidation [5]. The current correction devices are external fixators that leave unsightly scars and are prone to infection [6]. While recently developed intramedullary devices address many of the persistent issues with external lengthening devices, size limitations and potential damage to the bone growth plates make them impractical for use in children [7, 8]. The proposed research addresses an unmet need by developing a novel implantable extramedullary device for LLD correction that is targeted for pediatric use. The device will be implantable, submuscular, and fixed to the outside surface of the bone (extramedullary), thus allowing for use in children without concern for injury to the growth plates. The device’s function will be similar to an external fixator; however, it will not require exposed hardware, which increases risk of infection, or muscle penetration from the pins, which causes pain. Additionally, the device incorporates real-time control of the distraction rate, reducing the risk of complications arising from fixed rate distraction such as premature consolidation and non-union of the callus. [9–11]. The investigators of this study have previously designed and constructed a distraction mechanism prototype and test frame [10]. The current study aims to validate the real-time controller of the prototype.
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Barbosa, Paulo E. S., Misael Morais, Katia Galdino, Melquisedec Andrade, Luis Gomes, Filipe Moutinho, and Jorge C. A. de Figueiredo. "Towards medical device behavioural validation using Petri nets." In 2013 IEEE 26th International Symposium on Computer-Based Medical Systems (CBMS). IEEE, 2013. http://dx.doi.org/10.1109/cbms.2013.6627756.

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Tradewell, Michael, Steve Morin, and Kristin Chrouser. "Design and Validation of an Organizational Device for Endourological Surgery." In 2018 Design of Medical Devices Conference. American Society of Mechanical Engineers, 2018. http://dx.doi.org/10.1115/dmd2018-6839.

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Through a needs-based approach we sought to reduce instrument drops during endourological surgery. To this end, we designed and validated an endourology equipment organization device: the cord caddy. Iterative computer aided design and fused deposition model prototyping lead to the development of a machined functional prototype to accommodate the wide-variety of cables, cords, wires and equipment used in endourologic cases. Over 20 consecutive endourological surgeries, use of the cord caddy demonstrated that it met most of the design requirements, aside from disposability and basket/ureteroscope storage. Assessment of these requirements was precluded by the inability to test a sterile version of the device at our institution. Future plans include validating a sterile disposable device in the operating room.
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Ravizza, Alice, Federico Sternini, Alice Giannini, and Filippo Molinari. "Methods for Preclinical Validation of Software as a Medical Device." In 13th International Conference on Health Informatics. SCITEPRESS - Science and Technology Publications, 2020. http://dx.doi.org/10.5220/0009155406480655.

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Rajaram, Hamsini Ketheswarasarma. "Taxonomy Based Testing Using SW91, a Medical Device Software Defect Taxonomy." In 2018 IEEE 11th International Conference on Software Testing, Verification and Validation (ICST). IEEE, 2018. http://dx.doi.org/10.1109/icst.2018.00051.

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Wang, X., C. Di Natali, M. Beccani, M. Kern, P. Valdastri, and M. Rentschler. "Novel medical wired palpation device: A validation study of material properties." In 2013 Transducers & Eurosensors XXVII: The 17th International Conference on Solid-State Sensors, Actuators and Microsystems (TRANSDUCERS & EUROSENSORS XXVII). IEEE, 2013. http://dx.doi.org/10.1109/transducers.2013.6627102.

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Anderson, Jeff R., Silvia Ferrati, Chistof Karmonik, and Alessandro Grattoni. "Functional validation of an implantable medical dosing device by MRI at 3T." In 2014 36th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC). IEEE, 2014. http://dx.doi.org/10.1109/embc.2014.6944091.

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Etheridge, Michael, Harishankar Natesan, Radek Lopusnik, and Adam Cates. "Development and Validation of Numerical Model Simulation for RF Ablation Using the Isolator Synergy Clamp." In 2018 Design of Medical Devices Conference. American Society of Mechanical Engineers, 2018. http://dx.doi.org/10.1115/dmd2018-6949.

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Thermal ablation is rapidly becoming a standard of care for the treatment of atrial fibrillation (AF), a cardiac disorder characterized by irregular heart rhythm and estimated to impact more than 33 million people worldwide [1]. AtriCure is a company that specializes in epicardial ablation for AF and here we describe the development of a numerical model to study the performance of the Isolator® Synergy™ Clamp bipolar radiofrequency (RF) device. The clamp device features two jaws with embedded electrode pairs, which are used to secure the tissue by clamping across the left atrium (as shown in Figure 1). Energy is applied between the bipolar electrodes at approximately 460 kHz through an impedance-based control algorithm and is additionally duty-cycled between the pairs to further distribute the heating. Patient anatomies vary greatly and measured impedance will depend on atrial wall thickness, epicardial fat, electrode-tissue engagement, and structural variations. Further, tissue conductivity (inversely related to impedance) increases as the tissue is heated, leading to a complicated process, where the heat generation depends on the impedance, which in turn is a strong function of temperature. Energy delivery continues until a phase change in the tissue’s water content occurs, producing a sharp increase in impedance and termination of the ablation. Therefore, since tissue impedance and heating drive the device’s performance, a majority of the effort described here focuses on the validation work done to ensure the model is based on an accurate description of the tissue properties and response. While previous modeling of RF ablation often does include temperature-dependence of tissue properties, the referenced values vary notably and rarely include direct validation of modeling results to benchtop data. Variations in anatomy and fat content can dramatically impact the energy delivery and patient-to-patient treatment efficacy, so an accurate description of the tissue response is critical to understanding the limitations of current energy delivery algorithms and provides an invaluable tool in designing more efficacious ablation devices and algorithms.
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