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

[Marcelo]

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

 

[Sam Lazzara]

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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[Marcelo]

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.

 

[Sam Lazzara]

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

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

 

[Vitalix]

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

 

[François]

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?

 

[Ashley Fu]

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.

 

[Molfi_BA]

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

 

[planB]

ISO publications are copyright-protected.