Author: devventura

Insights into the Medical Device Benefit-Risk Analysis and Risk Management Report

Upon completion of the risk assessment, a comprehensive benefit-risk analysis is carried out. This vital step establishes the acceptability of product risk, carefully weighing the potential benefits against the identified risks. All of these critical measures culminate in the creation of a detailed risk management report, effectively summarizing the full range of risk management activities…

Unraveling the ISO 14971 Risk Assessment Process: Key Elements and Practical Insights

After determining the scope of the product risk management activities and documenting them in the Risk Management Plan, now the actual risk assessment can begin. In this article, we look at the various elements of what goes into a risk assessment for a product and how to determine the overall acceptability of the risks for…

Design with Risk in Mind: Crafting a Comprehensive Risk Management Plan for Medical Devices

When performing risk management activities for a medical device, those activities shall be planned according to the ISO 14971 risk management standard. The risk management process, if conforming to the standard, should include provisions for creating a Risk Management Plan to guide and govern the various steps involved in assessing the risk of the product….

Elements of Medical Device Risk Management ISO 14971

If you’re designing, marketing, or selling a medical device, you’re surely familiar with the fact that risk management is an ever increasingly important regulatory requirement and topic.  The international ISO standard for risk management is 14971:2019; with few exceptions, regulating bodies worldwide recognize ISO 14971 as the requirement for a risk management process that will…