The debate over ISO 14971 continues between industry and the European Commission. The joint ISO & IEC working group responsible for ISO 14971 met and determined that ISO 14971 still represents the state of the art for medical device risk management and that no changes were needed, despite the position of the EC that ISO...Read More

This document provides answers to questions that have been asked to notified bodies regarding using EN 62304 for regulatory purposes in the EU. FAQ 62304Read More