Risk management is a key portion of the medical device lifecycle, from design to discard. It applies to all class of devices regardless of where they are marketed. In the European Union, the Risk Management file is part of the device’s technical documentation demonstrating conformance to the Medical Device Directives. As a Harmonized Standard, EN ISO 14971:2012 can be used to demonstrate conformity to the Essential Requirements. It provides manufacturers with guidelines to follow to implement their Risk management process.
Changes were made to the informative annexes between the 2009 and 2012 versions of EN ISO 14971 to clarify the link between the European Directives and the Standard requirements.
The points covered in the webinar will include:
The reasons behind the revision
The changes and relationship between the Standard and the Directives
The main items to be taken into account to comply with the risk management requirement of the European Directive (using EN ISO 14971:2012)