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Understanding ISO 14971:2012: Changes to Annex Z and Impact on the Risk Management File
Learn about the discontinued support of the ALARP principle and how to address negligible risks, new requirements surrounding risk benefit analyses and mitigation strategies for risks that don’t include labeling.
ISO 14971 has long been the gold standard of risk management for medical device companies. Recently, several changes to Annex Z have been implemented in the 2012 revision which otherwise may go unnoticed but which have significant impact to the risk management file.
Learn about the discontinued support of the ALARP principle and how to address negligible risks, new requirements surrounding risk benefit analyses and mitigation strategies for risks that don’t include labeling. This discussion will use case studies to create a practical approach to modifying or creating your risk management file.
Why Should you Attend:
Risk management is a key part of a medical device design history. It is critical documentation that is often inspected and audited as part of regulatory body reviews. The number of 483s and warning letters associated with risk management are increased due to difficulty for companies to interpret ISO 14971:2012 and implement it appropriately.
Objectives of the Presentation:
Highlight key changes to ISO 14971:2012
Review Annex Z change impact to current risk management strategies
Learn how to update your risk management file to comply
Review case studies of real examples
Who can Benefit:
All medical device companies
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