Trying to understand the “state of the art” in medical device risk management? This diagram attempts to distinguish between ISO and European requirements.
If you are concerned about marketing your devices in Europe, don’t be fooled by the flowchart in the international version of ISO 14971:2007. It is
ISO 13485:2016 has a broader view of risk management than in the past.
Independence is the basis for judicial systems and sporting matches. And for quality systems, it is generally accepted that personnel who are independent of an