MEDDEV 2.7.1 and what it means for clinical evaluations and reports If you are a medical device manufacturer planning to sell your devices in Europe, you’re aware by now that there have been significant changes in EU regulations recently that affect how medical...
The area of genetic testing has expanded significantly in recent years with more types of testing becoming available for both clinical and non-clinical applications. The AMA states there are more than two thousand genetic tests available to aid in the diagnosis and...
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.
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