Regulatory aspects of medical devices and biomaterialsdoi:10.1016/B978-0-12-813477-1.00002-5Prabaha SikderSarit B. BhaduriBiomaterials in Translational Medicine
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Medical Devices: Regulatory Perspectives and Aspects of Regulatory Risk ManagementS. GestreliusA. Hensten-Pettersen
Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety This book is an essential read for anyone involved with the design, marketing or regulatory affairs aspects of medical devices. It should be in the ... G Higson,LT Myers - 《Medical Physics》 被引量: 22发...
It is used when manufacturers implement a full QMS, covering all aspects of device development, from design to manufacturing and final inspection. NBs thoroughly assess and approve these systems to ensure compliance with regulatory standards. This process is typically used for higher-risk devices. ...
“Regulators like the FDA should focus on those aspects of the AI/ML system that directly bear on its safety and effectiveness – in particular, how does it perform in the hands of its intended users?” A suggestion for Enhanced more involved clinical trials Provide individuals added flexibility...
With over 30 years of experience as a leading materials supplier to the industry, we understand the high level of support that device makers need to navigate the materials-related aspects of the regulatory process. Our partnership begins with the selection of polymers and continues through your mar...
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While waiting for an overall revision of the Negative List, pilot breakthroughs can be expected in certain aspects of foreign investment access restrictions in the CGT industry. For example, the Opinions on Further Optimizing th...
You can determine the classification for your product according to “The Rules for Classification of Medical Devices” (CFDA order No. 15 2015), the classification should be determined by the comprehensive judgment on three aspects: structural characteristics, form of operation and conditions for use...