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ISO 9001 and ISO 13485 PMS

ISO 13485 & EU MDR
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Guest user Created:   Mar 08, 2021 Last commented:   Mar 10, 2021

ISO 9001 and ISO 13485 PMS

ISO 13485 & EU MDR

Hi we are aiming at obtaining iso 13485 and 9001. Only one part of our complete product is MD1 ()medical device class 1.) so majority of product will fall under 9001 and minor part under 13485. However. When performing PMS/PSUR- do we need to perform it on the complete product or only on the part that is medical device?

 

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.
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Kristina Zvonar Brkić Mar 10, 2021

No, when performing PMS/PSUR, you need to cover only medical devices.

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Mar 10, 2021

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