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.
