White Papers
White Paper – Proposed QMSR Expert Analysis (Part 1)
On Feb. 23, 2022, the U.S. FDA published the Draft Proposed Rulemaking for the new “Quality Management System Regulation.” It’s imperative that the entire industry thoroughly understand the new proposal and any nuances. This White Paper is Part 1 of a series of...
Risk Management Series – Article 7 Part A: Determining Risk Acceptability
This article addresses the question: “Are we willing to accept the risks associated with our device given the benefits that a patient is likely to receive?”
Risk Management Series – Part 6: Estimating Probability of Occurrence
In our last article, Part 5: Assigning Harms and Severity, we addressed the importance of doing your “homework” before attempting to assess the severity of identified hazards/harms, clearly defining the use environment and user profile being considered, and...
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 3: Transferring Risks from Fault Trees to FMEAs
Foreword In our last article, Part 2: Using Fault Trees to Focus and Simplify Risk Analysis, we described the basic approach for conducting a Fault Tree Analysis (FTA) and the benefits of using FTA to conduct a comprehensive analysis of the causes of device failures...