Assuring Your ISO 14971 Risk Management Strategy Adopts a Holistic Approach

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• published: 10 Feb 2015
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Assuring Your ISO 14971 Risk Management Strategy Adopts a Holistic Approach US devicemakers have recently experienced shock, disappointment and downright anger because of failed EU audits. As of August 1, 2012 all US devicemakers that want to sell products in the EU must be in compliance with ISO 14971:2012 and in particular Annexes: ZA, ZB and ZC. These Annexes are commonly overlooked by devicemakers — but not by EU auditors. The Annexes are the informative part of ISO 14971:2012 and serve as "bridges" that link ISO 14971:2012 to the legal requirements in the Medical Device Directives. Failure to understand the nuances of the Annexes and how they need to be accounted for in your risk management and Quality Management Systems assessments can find you in noncompliance. This presentation, led by BSI's Technical Director, Dr. Ibim Tariah, will assure that the requirements found in the Annexes are incorporated into your risk management programs. Attendees will learn: • How to assure the EU's holistic approach to risk management and QMS assessment are covered in your risk management strategy • What auditors are looking for and ways to assure that your documentation meets EN ISO 14971:2012 and hence the MDDs requirements • Pointers to how firms can properly plan for and document their QMS assessments to ensure compliance with the MDDs Dr. Ibim Tariah, Technical Director, BSI Healthcare Solutions