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This checklist can be used to update relevant processes, procedures, templates and risk management plans and records from ISO 14971:2007/EN ISO 14971:2012 to ISO 14971:2019.
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This checklist can be used to update relevant processes, procedures, templates and risk management plans and records from ISO 14971:2007/EN ISO 14971:2012 to ISO 14971:2019. It references the “old” clauses and the relevant clauses in 2019.
Take a look at our online course: Introduction to Risk Management for Medical Devices and ISO 14971. Learn about the overall process of risk management, the tools and techniques used and how to develop a safe medical device according to regulatory requirements. Created by industry experts. Certification on successful completion of course.
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