For the purpose of the CE mark, our consultant prepared a post marketing surveillance (PMS) document and said that I should have (as part of the 13485) a procedure for how to prepare such a document. According to the post marketing surveillance document that our consultant prepared, I see that parts of this documents is based on procedures that are listed in different documents that you have provided (e.g., 08_Customer_Complaints_and_Feedback, 16_Adverse_Event_Investigation, and 15_Nonconformities). I wonder if you have a single document that describes the procedures for a PMS review.
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ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Expert
Kristina Zvonar Brkić
Jul 04, 2022
Yes we have a procedure for a Post-market surveillance system. You can see its preview on the following link:
- Procedure for Post-Market Surveillance System https://advisera.com/13485academy/documentation/procedure-for-post-market-surveilance/
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Jul 04, 2022
Jul 04, 2022
Jul 04, 2022