Expert Advice Community

Home / ISO 13485 & EU MDR / New requirements for technical files

Guest

New requirements for technical files

ISO 13485 & EU MDR
  Quote
Guest
Guest user Created:   Apr 02, 2021 Last commented:   Apr 06, 2021

New requirements for technical files

ISO 13485 & EU MDR

We are working through our documentation with the help of Advisera. I do have questions on the new requirements for technical files. Do you have any samples or templates available?

Tags: Product: ISO 13485 & MDR Integrated Documentation Toolkit
0 0

Assign topic to the user

ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 & EU MDR INTEGRATED DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.
Expert
Kristina Zvonar Brkić Apr 06, 2021

You have a template for technical documentation in the folder Technical file. The name of the document is the Technical file template.  

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Apr 02, 2021

Apr 06, 2021

Suggested Topics
Guest user Created:   Jun 08, 2021 ISO 13485 & EU MDR
Replies: 1
0 0

Biggest challenge when seeking EU MDR compliance
Guest user Created:   May 31, 2019 ISO 13485 & EU MDR
Replies: 1
0 0

Can the same set of documents be used for the new company?
Guest user Created:   Jun 15, 2026 ISO 13485 & EU MDR
Replies: 1
0 0

Templates: Technical Documentation for Medical Device & CER

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.