Medical Device Implications of EN ISO 14971:2012

Risk Management is a fundamental step for medical device manufacturers to demonstrate compliance to the EU Directives for Medical Devices, ensuring the safety of patients and users.

Since the advent of the new version of EN ISO 14971:2012 Medical devices – application of risk management to medical devices, the additional clarification within the standard has led to a number of misconceptions and confusion surrounding the implementation of the new standard by Medical Device Manufacturers. Some companies were left in some cases scratching their heads about how exactly they were going to implement the new standard.

This whitepaper will help medical device manufacturers understand the changes made to the EN harmonized version of ISO 14971:2012 and provide guidance on what is expected of the manufacturer to comply with the standard.