White Papers

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 – Part 5: Assigning Harms and Severity

Introduction One of the most challenging elements of risk analysis is the assignment of Harms and Severities to a particular hazardous situation. On the surface, describing the consequences of the sequence of actions that lead to exposure to a hazard seems pretty...

Risk Management Series – Part 4: Key Terms

Introduction Before diving into the best practices for conducting a risk assessment, it’s important to clarify some terminology. ISO 14971:2019 (the Standard) and TR 24971 (the Guidance) provide helpful definitions and examples, but even with that, the use of some...
Risk Management Series – Part 4: Key Terms

Risk Management Series – Part 4: Key Terms

Introduction Before diving into the best practices for conducting a risk assessment, it’s important to clarify some terminology. ISO 14971:2019 (the Standard) and TR 24971 (the Guidance) provide helpful definitions and examples, but even with that, the use of some...

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Risk Management Series Introduction – Beyond FMEA

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...

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