Oct 15, 2020 | Risk Management
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...
Aug 9, 2020 | Risk Management, Documents
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...
Jul 9, 2020 | Risk Management
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...
Jun 9, 2020 | Risk Management
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...
Jun 5, 2020 | Risk Management
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...
May 9, 2020 | Risk Management
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...