SPRING DISCOUNT
Get 30% off on toolkits, course exams, and Conformio yearly plans.
Limited-time offer – ends April 25, 2024
Use promo code:
SPRING30

Expert Advice Community

Guest

ISO 13485, clause 4.2.3 Medical Device File

  Quote
Guest
Guest user Created:   Dec 16, 2020 Last commented:   Dec 13, 2022

ISO 13485, clause 4.2.3 Medical Device File

Does a service company who is only transporting medical devices from point a to point b, have to have a Medical Device File, ISO 13485, clause 4.2.3? I won't think so. Isn't this not applicable since they are only transporting goods from point A to point B.
0 0

Assign topic to the user

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Dec 16, 2020

Clause 4.2.3 is not possible to exclude or mark as not applicable. It means that you need to have the following documents in your Medical device file: CE certificate of the medical device and any special instruction or label about storage and transport conditions. Maybe there are more documents considering the nature of the medical device, but generally, those two documents are enough.

Quote
0 0
Guest
HS Dec 10, 2022

I understand if I am the device holder but if I am contractor making a medical device component and not the finished device why is this still necessary

Quote
0 0
Expert
Kristina Zvonar Brkić Dec 13, 2022

In that case, you need to have a medical device file for the component that you produce. This means the specification for this component, if applicable some instructions on how your component is integrated into the final medical device, label, and any other kind of instructions (instructions of use, instructions for cleaning).

Quote
0 1

Comment as guest or Sign in

HTML tags are not allowed

Dec 16, 2020

Dec 13, 2022

Suggested Topics