Trying to understand the “state of the art” in medical device risk management? This diagram attempts to distinguish between ISO and European requirements.
Category Archives: Risk Management
Clinical evaluation & investigation in Europe MDR
Want a good career with lots of job security? Learn how to perform clinical evaluations or run clinical investigations.
Quality System Process Risk Management (ISO 13485:2016)
ISO 13485:2016 has a broader view of risk management than in the past.
