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Question-MDR

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Guest user Created:   Dec 06, 2021 Last commented:   Dec 07, 2021

Question-MDR

We are preparing our "Technical Documentation" documents for Class I products. Our partner company provide us the attached GSPR form which should be filled out for each product. But I did not find such form in the documents I purchased from you. I guess, we have a new document instead. Can you please let me know which document should be used as GSPR for Class I products?
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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 Dec 07, 2021

Yes, you are right, we did not have in our documentation toolkit GSPR list. We are just preparing it and it will be issued by the end of this year. So, if you have given this one, feel free to use it. 

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Dec 06, 2021

Dec 07, 2021