Medical devices. Post-market surveillance for manufacturers Ingestion-build-224916 Annex C (informative) Background to

Annex C (informative) Background to the BS 7121 series

2 Reverification tests

it does not cover the following items which

Any entity related to the production of respiratory protective devices

Medical devices. Post-market surveillance for manufacturers Ingestion-build-224916 Annex C (informative) Background toWhat 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