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…
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…
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….
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…
By Shant Youkhana, Director of Quality and Strategic Solutions The Corrective and Preventative Action (CAPA) system is a regulatory requirement to which all Medical Device, Pharmaceutical, and Combination Product manufacturers must comply. Although there are minor differences between the CAPA system requirements in the Medical Device and Pharmaceutical industries, the overall purpose remains the same:…
by Charles Ventura, President Design Controls, do we really have to follow them? Design Control is a topic that medical device professionals seem to either love or hate. Many Engineers call Design Controls, “the paperwork” or “just the documentation”, and rarely seem to value them. The thought of having to create the Design Control documentation…
