Documents for distribution company

1. We are trying to determine which documents in your 'ISO 13485 & MDR Integrated Documentation Toolkit' are required for a 'distribution company' distributing medical devices. Understanding this more clearly will help to us to secure funding to purchase.

In my opinion, if you are a distributor, you do not need ISO 13485 & MDR Integrated Documentation toolkit“, for your purposes is ok ISO 13485:2016 Documentation toolkit that you can find on the following link: https://advisera.com/13485academy/iso-13485-documentation-toolkit/ ISO 13485 & MDR Integrated Documentation toolkit refers directly to medical device manufacturers who are responsible for certifying medical devices and placing products on the market. 

2. For use of this pack for a 'distribution company', can you please update your 'ISO 13485 & MDR Integrated Documentation Toolkit' document with an additional column indicating which procedures would be needed. This will help to convince management on the necessity to purchase the pack

All documents that are on the list of ISO 13485:2016 documentation toolkit are mandatory, expect the sterilization part. Please, keep in mind that ISO 13485:2016 applies equally to production and service. In your case, you are providing a distribution service. This means that where the documentation indicates „Production“, in your case it is a Distribution Service.

Thank you for response. Ok, which procedures in the ISO 13485:2016 Documentation toolkit are applicable to a distribution company distributing medical devices. Or to reword, which procedures are exempt.

From ISO 13485:2016 Documentation toolkit, in my opinion, you can exempt the following documents: Design and development, Sterilization and Adverse event investigation. Procedure Production and service provision in your case will be Service provision.