The integration of Artificial Intelligence in medical devices is revolutionizing healthcare delivery, with the potential to improve patient outcomes, reduce costs, and increase access to care. From diagnostic systems to imaging devices, AI is being used in various...
The De Novo classification process is a risk-based approach for classifying novel medical devices that had previously been automatically placed in Class III, the highest United States device classification. On October 4, 2021, the US Food and Drug Administration (FDA)...
White Paper on Transition Plan for Medical Devices that fall within enforcement policies and EUAs issued during the COVID-19 Public Health Emergency. The FDA has provided their thoughts on 180-day transition plans to get back to standard practices (compliance with the...
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 2 of a series of...
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...
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?”
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...
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...
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...
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...