Expert Advice Community

Home / ISO 13485 & EU MDR / Product Sample ISO 13485

Guest

Product Sample ISO 13485

ISO 13485 & EU MDR
  Quote
Guest
Guest user Created:   Oct 11, 2018 Last commented:   Oct 11, 2018

Product Sample ISO 13485

ISO 13485 & EU MDR
Sir how long we have to save the sample product in case of ISO 13485 certified company/
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
Verlene Law Oct 11, 2018

Answer:
The Standard does not state how long the sample product should be kept. Generally, it should follow applicable regulatory guidelines or the projected useful life of the medial device depending on whichever is the longest.

For more information, please refer to :

Record of Production Process Validation
https://advisera.com/13485academy/documentation/record-of-production-process-validation-iso-13485-2016/

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Oct 11, 2018

Oct 11, 2018

Suggested Topics
Guest user Created:   Sep 30, 2020 ISO 13485 & EU MDR
Replies: 1
0 0

Sterilization procedure template
Guest user Created:   May 24, 2021 ISO 13485 & EU MDR
Replies: 1
0 0

Test method validation
Guest user Created:   May 17, 2021 ISO 13485 & EU MDR
Replies: 1
0 0

Questions about the implementation

This website stores cookies on your computer. These cookies are used to collect information about how you interact with our website and allow us to remember you. We use this information in order to improve and customize your browsing experience and for analytics and metrics about our visitors both on this website and other media. To find out more about the cookies we use, see our Privacy Policy.

If you decline, your information won't be tracked when you visit this website. A single cookie will be used in your browser to remember your preference not to be tracked.