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ISO 9001 and ISO 13485 PMS
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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Kristina Zvonar Brkić
Mar 10, 2021
No, when performing PMS/PSUR, you need to cover only medical devices.
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Mar 08, 2021
Mar 10, 2021
Mar 10, 2021