ISO 14971:2019 and the current state of risk management


ISO 14971 is globally recognized in the medical device industry, referenced in numerous publications and other standards, and acknowledged as a consensus standard; that is, its concepts are embedded within the Risk Management and Quality Management Systems of organizations worldwide. 

The International Organization for Standardization reviewed ISO 14971, following the normal ISO “Systematic Review” process used to ensure that its standards remain up to date and globally relevant. Based on this review, it became clear that the then-current second edition of ISO 14971 enjoyed global acceptance and was widely recognized in the medical device community, and that its core concepts and approach to risk management should be maintained. That said, there was also recognition that some updates were needed to clarify the normative requirements and provide additional guidance on their application. Particular areas of focus included:

  • Production and Post-Production Information
  • Clinical Benefits and Benefit-Risk Analysis

Other changes were also introduced, including new and revised definitions, clarification to the scope of ISO 14971 and its relationship to other standards, and numerous other refinements.

The changes reflected in ISO 14971:2019 may appear subtle, but because of its broad reach and regulatory implications, changes to the standard must be analyzed to ensure ongoing regulatory compliance. That is, documents and processes may need revision and update, as the new state of the art presented in the Standard may have greater impact than first impressions might suggest.  Of course, any changes will require due consideration of the timelines that may be needed for implementation. This webinar is intended to highlight some of the key areas where the standard was changed technically, and where guidance was either introduced or expanded.

Presenter:
Ken Pilgrim has over 20 years of industry experience at the Manager/Director level, overseeing corporate quality systems and providing input on business decisions and strategy, regulatory oversight, and risk management strategies for existing and new products. Ken specializes in regulatory submissions, including those for IVDs, implantable devices, and tissue products. His expertise includes international regulatory compliance such as MDR/IVDR support and strategy; 510(k) clearances and other FDA activities, such as Pre-Sub meetings and 513(g)s; Class II–IV Medical Device Licenses for Health Canada; EU Technical Files (MD / IVD); Risk Management files; and global regulatory strategy. Ken’s quality system background includes: implementing quality management systems (QMS) and supplier audits to FDA QSR, J-GMP, ISO 13485, and MDSAP. Additionally, Ken oversees Emergo by UL’s RA/QA Consulting activity in Canada. In this role, he has peer reviewed 100+ regulatory filings and reports.