
Tag: Risk Management


TC 210 Not Ready to Adopt Definition of Risk Outlined in Annex SL

TC 176 Plans to Correct Mistakes Made With the Introduction of “Risk-Based Thinking” in ISO 9001:2015 | Opinion

Recognition of EN ISO 14971 as a harmonized standard in support of the European Medical Device Regulations

If you’re going to cite operator error, do it in the PFMEA
