Seapine Software (seapine.com) which provides a variety of development tools published its 2014 report on the state of software development for medical devices. This report was generated based on input from 500 individuals in the medical device industry. It contains a breakdown of risk management methods used, key documentation challenges, requirements management approaches used, test...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.