ISO TR 20416 Medical Devices - Post-Market Surveillance for Manufacturers

Sam Lazzara

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For those not aware, ISO TC 210 WG 6 is developing a document on PMS, titled ISO TR 20416 Medical devices -- Post-market surveillance for manufacturers. The idea of the document is to give guidance on PMS processes for manufacturers

Thanks Marcelo. Any idea when a public draft will be available for review.

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Hi everyone,

The ISO TR/20416 has finally been published in july 2020.

As I've a limited budget and lots of standards have been published lately, I may wait for the EN version to ensure I'm compliant with MDR requirements, except if its content is really useful to put in place a good PMS proccess. Did someone have a look at it?
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