The growing changes in the regulatory requirements emphasizes the need to strengthen risk management activities. With EU MDR and US FDA, there is gaining importance on the benefit-risk language among regulators. This 3rd edition of the ISO 14971 strengthens the benefit-risk language and instruct the device manufacturers on how to best put together the risk management process. This whitepaper gives the overview of the 3rd edition changes in ISO 14971.In this whitepaper, the major revision and clarifications of the 3rd edition are provided. Detailed description about the Reason for changes, revised structure are included. Clause wise changes with schematic representation are discussed. Highlights on the summary of the changes are encapsulated in a prescribed way. Download the whitepaper to read more
