White Papers
Risk Management Series – Part 2: Using Fault Trees to Focus and Simplify Risk Analysis
In our previous article (Part 1: Prioritizing Risk Management Activities), we described an approach for identifying the design element(s) or process stages(s) to prioritize when conducting a comprehensive risk analysis. This prioritization helps to ensure that the...
Risk Management Series – Part 1: Prioritizing Risk Management Activities
Forward: This second article in our series addresses a common risk analysis problem: prioritization. In large medical device companies, the email invitation to an FMEA session can strike fear (or at least dread) into the hearts of engineers and other members of the...
Risk Management Series Introduction – Beyond FMEA
Forward: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 and invitro diagnostic industry. The intent of the series is to provide practitioners with insight into how to...