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.
Health hazard analyses (HHAs) are a necessary part of the medical device manufacturing process since the FDA revised Medical Device Good Manufacturing Practices Regulation, 21 CFR Section 820 in 1996. They were replaced with the Quality System regulations and included...
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