Medical devices. Post-market surveillance for manufacturers
Medical devices. Post-market surveillance for manufacturers
What is ISO/TR 20416 about?
ISO/TR 20416 provides guidance on the post-market surveillance process for medical device manufacturers. As manufacturers of medical devices, feedback from users is an important step to evolve your products. ISO/TR 20416 describes a proactive and systematic process that you can use to collect and analyse such data. This feedback helps you to meet the applicable regulatory requirement to gain experience from the post-production activities. Post-market surveillance is the process by which manufacturers collect and analyze data which can subsequently be used for product realization, risk management, communicating to regulatory authorities, or product improvement. ISO TR 20416 is a new international technical report giving guidance on how best to collect and analyze post-market medical devices surveillance data.
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