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

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

Marcelo Antunes said:

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

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


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Sam Lazzara said:

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


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It's still in the early stage pf development, so it will take some time, there's no expected timeframe yet.

Marcelo Antunes said:

It's still in the early stage pf development, so it will take some time, there's no expected timeframe yet.

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Does anyone have any idea when the first public draft will be available for review?

Hello, the draft seems to be available for 20 pounds from BSI shop: 19/30401776 DC - PD ISO/TR 20416. Medical devices. Post-market surveillance for manufacturers

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?

ISO/TR 20416: Best Practices for Medical Device Postmarket Surveillance - Oriel STAT A MATRIX Blog

You can get some information about ISO /TR 20416 in the above web page.
I am also waiting for the ISO /TR 20416 for free if possible.

Hi! Anybod knows where I can find this standard for free? THANKS!

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