Journal articles on the topic 'Medical devices certification'
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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 textGeremia, 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 textUmamaheswara 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 textKaule, 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 textJanß, 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 textMijares, 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 textFoo, 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 textAbela, 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 textZarmani, 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 textMaresova, 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 textGrossmann, Swen, Stefan Siewert, Robert Ott, Klaus-Peter Schmitz, Stefanie Kohse, Wolfram Schmidt, and Niels Grabow. "Standardized technique of water permeability measurement for biomedical applications." Current Directions in Biomedical Engineering 4, no. 1 (September 1, 2018): 633–36. http://dx.doi.org/10.1515/cdbme-2018-0152.
Full textKinney, Eleanor D. "The Corporate Transformation of Medical Specialty Care: The Exemplary Case of Neonatology." Journal of Law, Medicine & Ethics 36, no. 4 (2008): 790–802. http://dx.doi.org/10.1111/j.1748-720x.2008.00338.x.
Full textdu Preez, W. B., and G. J. Booysen. "Qualification of Customised Medical Implants Produced by Ti6Al4V(ELI) Additive Manufacturing." MATEC Web of Conferences 321 (2020): 03012. http://dx.doi.org/10.1051/matecconf/202032103012.
Full textDi Nardo, Matteo, Leen Vercaemst, Justyna Swol, Nicholas Barret, Fabio S. Taccone, Maximilian V. Malfertheiner, Lars M. Broman, et al. "A narrative review of the technical standards for extracorporeal life support devices (pumps and oxygenators) in Europe." Perfusion 33, no. 7 (May 24, 2018): 553–61. http://dx.doi.org/10.1177/0267659118772452.
Full textKost, Gerald J. "Preventing Medical Errors in Point-of-Care Testing." Archives of Pathology & Laboratory Medicine 125, no. 10 (October 1, 2001): 1307–15. http://dx.doi.org/10.5858/2001-125-1307-pmeipo.
Full textReich, Norbert. "Product Liability and Beyond: An Exercise in Gap-Filling." European Review of Private Law 24, Issue 3/4 (June 1, 2016): 619–43. http://dx.doi.org/10.54648/erpl2016038.
Full textCaldicott, Catherine V. "A ‘Period of Maladjustment’:." Journal of Medical Regulation 103, no. 4 (January 1, 2017): 24–31. http://dx.doi.org/10.30770/2572-1852-103.4.24.
Full textHentschel, Lukas, Frank Kynast, Sandra Petersmann, Clemens Holzer, and Joamin Gonzalez-Gutierrez. "Processing Conditions of a Medical Grade Poly(Methyl Methacrylate) with the Arburg Plastic Freeforming Additive Manufacturing Process." Polymers 12, no. 11 (November 12, 2020): 2677. http://dx.doi.org/10.3390/polym12112677.
Full textdu Preez, W. B., D. J. de Beer, and G. J. Booysen. "Establishing a Quality Management System for Production of Certified Customised Titanium Medical Implants through Additive Manufacturing." MRS Advances 5, no. 26 (2020): 1387–96. http://dx.doi.org/10.1557/adv.2020.192.
Full textPeel, Sean, Dominic Eggbeer, and Peter Dorrington. "Standardizing the patient-specific medical device design process via a paper-based pro-forma." Journal of Design, Business & Society 6, no. 2 (October 1, 2020): 233–58. http://dx.doi.org/10.1386/dbs_00013_1.
Full textPecchia, Leandro, Davide Piaggio, Alessia Maccaro, Claudio Formisano, and Ernesto Iadanza. "The Inadequacy of Regulatory Frameworks in Time of Crisis and in Low-Resource Settings: Personal Protective Equipment and COVID-19." Health and Technology 10, no. 6 (May 2, 2020): 1375–83. http://dx.doi.org/10.1007/s12553-020-00429-2.
Full textKielo-Viljamaa, Emilia, Eva Collanus, Janne Lahtiranta, and Antti Tuomisto. "Maturity of health care testbeds – A qualitative mapping at the Nordic context." Finnish Journal of eHealth and eWelfare 14, no. 1 (April 14, 2022): 92–103. http://dx.doi.org/10.23996/fjhw.111734.
Full textPereira Azevedo, Nuno, Stavros Gravas, and Jean de la Rosette. "Mobile Health in Urology: The Good, the Bad and the Ugly." Journal of Clinical Medicine 9, no. 4 (April 3, 2020): 1016. http://dx.doi.org/10.3390/jcm9041016.
Full textHossain, Md Anwar, Mohiuddin Ahmad, Md Rafiqul Islam, and Yadin David. "Evaluation of Performance Outcomes of Medical Equipment Technology Management and Patient Safety: Skilled Clinical Engineer’s Approach." Global Clinical Engineering Journal 1, no. 2 (March 21, 2019): 4–16. http://dx.doi.org/10.31354/globalce.v1i2.46.
Full textOh, Jai-woo, Jin-Kyu Kang, and Og-Woo Yoo. "A Study on the Automatic Control System for Quality Assurance of Clinical Pathology Examination Applying Machine Learning Technology." Webology 19, no. 1 (January 20, 2022): 4459–81. http://dx.doi.org/10.14704/web/v19i1/web19294.
Full textPeter, Lukas, Ladislav Hajek, Petra Maresova, Martin Augustynek, and Marek Penhaker. "Medical Devices: Regulation, Risk Classification, and Open Innovation." Journal of Open Innovation: Technology, Market, and Complexity 6, no. 2 (June 10, 2020): 42. http://dx.doi.org/10.3390/joitmc6020042.
Full textLenters-Westra, Erna, and Robbert J. Slingerland. "Three of 7 Hemoglobin A1c Point-of-Care Instruments Do Not Meet Generally Accepted Analytical Performance Criteria." Clinical Chemistry 60, no. 8 (August 1, 2014): 1062–72. http://dx.doi.org/10.1373/clinchem.2014.224311.
Full textHuhn, Sophie, Miriam Axt, Hanns-Christian Gunga, Martina Anna Maggioni, Stephen Munga, David Obor, Ali Sié, et al. "The Impact of Wearable Technologies in Health Research: Scoping Review." JMIR mHealth and uHealth 10, no. 1 (January 25, 2022): e34384. http://dx.doi.org/10.2196/34384.
Full textSarradon-Eck, Aline, Tiphanie Bouchez, Lola Auroy, Matthieu Schuers, and David Darmon. "Attitudes of General Practitioners Toward Prescription of Mobile Health Apps: Qualitative Study." JMIR mHealth and uHealth 9, no. 3 (March 4, 2021): e21795. http://dx.doi.org/10.2196/21795.
Full textParicharak, Sukanya, Atul Baravkar, Apeksha Masal, Sushma Chougule, Pooja Deshmane, and Sachin Kulkarni. "A comprehensive synopsis on cognizance of Regulatory Affairs in different sectors of Pharmacy." International Journal of Drug Regulatory Affairs 9, no. 4 (December 26, 2021): 20–32. http://dx.doi.org/10.22270/ijdra.v9i4.495.
Full textNistor, Cristina, and Catherine Tucker. "Certification Intermediaries: Evidence from the Medical Device Industry." Academy of Management Proceedings 2016, no. 1 (January 2016): 14314. http://dx.doi.org/10.5465/ambpp.2016.14314abstract.
Full textMalvehy, Josep. "Risks and Benefits of Artificial Intelligence in Teledermatology." Iproceedings 8, no. 1 (February 18, 2022): e36891. http://dx.doi.org/10.2196/36891.
Full textMatsuhama, Maki, Tomoko Takishita, Ryosuke Kuribayashi, Kazunori Takagi, Rika Wakao, and Kenichi Mikami. "Similarities and Differences of International Practices and Procedures for the Regulation for Active Substance Master Files/Drug Master Files of Human Use: Moving Toward Regulatory Convergence." Journal of Pharmacy & Pharmaceutical Sciences 19, no. 2 (August 8, 2016): 290. http://dx.doi.org/10.18433/j37g80.
Full textMatsuhama, Maki, Tomoko Takishita, Ryosuke Kuribayashi, Kazunori Takagi, Rika Wakao, and Kenichi Mikami. "Similarities and Differences of International Practices and Procedures for the Regulation for Active Substance Master Files/Drug Master Files of Human Use: Moving Toward Regulatory Convergence." Journal of Pharmacy & Pharmaceutical Sciences 19, no. 2 (August 8, 2016): 290–300. http://dx.doi.org/10.18433/jpps.v19i2.27066.
Full text&NA;. "Applied Imaging Receives Certification to the International Medical Device Standard." Journal of Clinical Engineering 31, no. 2 (April 2006): 76. http://dx.doi.org/10.1097/00004669-200604000-00017.
Full textOehme, L., O. Lindner, D. Hellwig, and J. Kotzerke. "Positron emission tomography 2008 in Germany." Nuklearmedizin 49, no. 02 (2010): 58–64. http://dx.doi.org/10.3413/nukmed-0203.
Full textDraman, Wan Mohd Ashraf Adlin Wan, Jeong Chun-Phuoc, and Mohd Shukri Ab Yajid. "Halal certification of medical device in Malaysia: A shariah analysis into the compliance process and legal requirements." International Journal of Medical Toxicology & Legal Medicine 22, no. 3and4 (2019): 94. http://dx.doi.org/10.5958/0974-4614.2019.00066.4.
Full textMendonça, José Manuel, Nuno Cruz, Daniel Vasconcelos, Carla Sá-Couto, António P. Moreira, Paulo Costa, Hélio Mendonça, Ariane Pereira, Zakaria Naimi, and Vladimiro Miranda. "Pneuma: entrepreneurial science in the fight against the COVID-19 pandemic - a tale of industrialisation and international cooperation." Journal of Innovation Management 8, no. 4 (February 13, 2021): 3–25. http://dx.doi.org/10.24840/2183-0606_008.004_0002.
Full textHUANG, HUNG-CHUN, CHIA-HUNG CHIEN, CHENG-YI WANG, and FOK-CHING CHONG. "EVALUATING THE UNCERTAINTY OF MEASUREMENT ON BLOOD'S GLUCOSE LEVEL." Biomedical Engineering: Applications, Basis and Communications 17, no. 02 (April 25, 2005): 91–96. http://dx.doi.org/10.4015/s1016237205000147.
Full textAdham, Khairul Akmaliah, Mohd Fuaad Said, Saida Farhanah Sarkam, and Nur Sa’adah Muhamad. "GranuLab: Strategies for Growth." Asian Case Research Journal 19, no. 02 (December 2015): 443–71. http://dx.doi.org/10.1142/s0218927515500169.
Full textSnyder, Marion L., Alexis Carter, Karen Jenkins, and Corinne R. Fantz. "Patient Misidentifications Caused by Errors in Standard Bar Code Technology." Clinical Chemistry 56, no. 10 (October 1, 2010): 1554–60. http://dx.doi.org/10.1373/clinchem.2010.150094.
Full textBrijnath, Bianca, Nabita Singh, and Danielle Mazza. "Stakeholder perspectives on the new sickness certificate in Victoria: results from a mixed-methods qualitative study." Australian Health Review 40, no. 1 (2016): 27. http://dx.doi.org/10.1071/ah14136.
Full textNistor, Cristina, and Catherine Tucker. "Third Party Certification: The Case of Medical Devices." SSRN Electronic Journal, 2015. http://dx.doi.org/10.2139/ssrn.2554984.
Full textFujikawa, Joji, Ryoma Morigaki, Nobuaki Yamamoto, Teruo Oda, Hiroshi Nakanishi, Yuishin Izumi, and Yasushi Takagi. "Therapeutic Devices for Motor Symptoms in Parkinson’s Disease: Current Progress and a Systematic Review of Recent Randomized Controlled Trials." Frontiers in Aging Neuroscience 14 (March 29, 2022). http://dx.doi.org/10.3389/fnagi.2022.807909.
Full text"Knowledge, Attitude and Awareness towards the Usage of Halal Medical Devices in Shah Alam, Selangor." Social & Management Research Journal 18, no. 2 (February 28, 2022): 255–70. http://dx.doi.org/10.24191/smrj.v18i2.15397.
Full textPrayitno, Lukman, and Max Joseph Herman. "Perdagangan Bebas Produk Farmasi dan Alat Kesehatan serta Kesiapan Memenuhi Persyaratan Cetak Biru Masyarakat Ekonomi ASEAN." Jurnal Kefarmasian Indonesia, February 24, 2020, 67–78. http://dx.doi.org/10.22435/jki.v10i1.1966.
Full textMastrandrea, G., F. Cangialosi, P. Notarangelo, G. Chetta, and E. A. Graps. "New organizational model to foster good practice. Central venous access management in cancer patients." European Journal of Public Health 30, Supplement_5 (September 1, 2020). http://dx.doi.org/10.1093/eurpub/ckaa166.045.
Full textBoudreau, Martha A. "Abstract 229: Cardiopulmonary Resuscitation Compliance of Clinical Nurses Using Feedback Technology from the Zoll R Series Defibrillator." Circulation 142, Suppl_4 (November 17, 2020). http://dx.doi.org/10.1161/circ.142.suppl_4.229.
Full textGoda, Ibrahim, Mourad Nachtane, Yumna Qureshi, Hamza Benyahia, and Mostapha Tarfaoui. "COVID-19: Current challenges regarding medical healthcare supplies and their implications on the global additive manufacturing industry." Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine, January 22, 2022, 095441192110703. http://dx.doi.org/10.1177/09544119211070373.
Full textKoenig, C., P. Hellebart, J. Koch, F. Egger, T. Puntus, R. Kriz, K. Huber, M. Nuernberg, and D. Zweiker. "Is diversity harmful? - Mixed-brand cardiac implantable electronic devices undergoing magnetic resonance imaging." EP Europace 23, Supplement_3 (May 1, 2021). http://dx.doi.org/10.1093/europace/euab116.480.
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