The past 7 months were certainly challenging as we endeavored to write procedures, train out employees and implement our 9001 system, however, this task would have been impossible were it not for your supervision, your guideance and your sense of humour. Words alone cannot convey our true sense of appreciation. We wish you continued success in your ISO consulting business and we will heartily recommend your firm to anyone who approaches us seeking such services.-TP Composites

Personal tools
You are here: Home → News → Risk Management for Medical Devices and In-Vitro Diagnostic Medical Devices
 

Risk Management for Medical Devices and In-Vitro Diagnostic Medical Devices

Important Information for any Organisation with CE Marked Products in the Medical Device and In-Vitro Diagnostic Medical Device Industries.

iso 14971:2007


The Standard for Risk Management ISO 14971 has been updated as was issued in 2007. There are some important differences, but probably the most noticeable is the section covering In-Vitro Diagnostic Medical Devices which is much more detailed and now is actually helpful as it provides examples and gives clarification on many issues that were somewhat vague in the previous version of the standard.


Document Actions