BS EN ISO 14971:2012, Medical Device Risk Management, was released July 6, 2012. This revision changes only the EN version and not the ISO version. With regards to the EN version, more informative references have been added between the standard and the medical device directive (MDD 93/42/EEC). Some of these changes may present a challenge to medical device manufacturer’s that have CE marked products that they are marketing in Europe. OMEDtech offers Risk Management consulting services to help companies navigate the requirements of the standards.
About UsOMEDtech, provides quality system design, regulatory, compliance, clinical and operations consulting services that are focused on helping managers and companies meet the aggressive challenges of bringing new medical device products to market.
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