In 2000, the first edition of ISO 14971 was released as the international standard for risk management of medical devices. This year, the ISO technical committee (ISO/TC 210) has been hard at work updating this globally-recognized standard. And while the fundamental...
Risk Management Series – Part 4: Transferring Risks from Fault Trees to FMEAs MEDIcept is presenting this ongoing series of articles focused on the conduct of risk management in the medical device industry to provide practitioners with insight into how to apply risk...
Risk Management Series – Part 3: Using Fault Trees to Focus and Simplify Risk Analysis MEDIcept is presenting this as an ongoing series of articles focused on the conduct of risk management in the medical device industry. The intent of the series is to provide...
Medical Device Risk Management Series – Part 2: Prioritizing Risk Management Activities This second article in our series addresses a common risk analysis problem – prioritization. In large medical device companies, the email invitation to a Failure Mode...
Risk Management White Paper Download MEDIcept is presenting this paper as an introduction to an ongoing series of articles focused on the conduct of risk management in the medical device industry.
Risk Management Series – Article 10: Human Factors Evaluation Report Forward: MEDIcept is very active in both assessing device usability and integrating the outputs of usability studies into other elements of manufacturers’ Quality Management Systems (QMS),...
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