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Medical Devices (includes In Vitro Diagnostics)
Applied
Jose Justiniano, MS Eng, MBA, RAC, CQE, CRE, CQA, CSSBB, CQM&OE
Director, Design Control, Risk Management & Human Factors Engineering
Ethicon Endo Surgery Inc
Barbara Young, CQE, CQA, CBA, CRE, CQM/OE
Medical Device and Risk Manager expert for MDR, IVDR, Supplier Quality
EN ISO 13485:2016 implemented the ability to use risk based decision making within the Quality Management System. Now Medical Device and In Vitro Device manufacturers may be struggling with how to implement a process which will also be support by the various regulatory agencies such as the FDA and Notified Bodies. This session will discuss strategic approaches to using the Risk Management File developed out of the implementation of ISO 14971:2012, which most manufactures are using for their risk management methodology, for product related risk-based decision making.