Having trouble keeping up with standards activity? You are not alone! The pace of new and emerging standards creates a challenge for even the most organized and well staffed software and quality assurance teams. Whether it is digital health, risk management, software process, usability, or the ever challenging cybersecurity, being aware and understanding upcoming changes...Read More
Updated Risk Management training course now available. Includes:
Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
Why FMEA is incomplete for medical device risk management.