Expert Advice Community

Home / ISO 13485 & EU MDR / Compliance with ISO 13485 or GMP for Class III device

Guest

Compliance with ISO 13485 or GMP for Class III device

ISO 13485 & EU MDR
  Quote
Guest
Guest user Created:   Nov 08, 2018 Last commented:   Nov 08, 2018

Compliance with ISO 13485 or GMP for Class III device

ISO 13485 & EU MDR
Hello, There is a requirement for planning the plant for medical device class 3 production(dermal filler) another than ISO 13845? The plant will be under demand of ISO 13845 or under GMP demand? In Europe.
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 Nov 08, 2018

Answer:

It should have a Quality Management System in place to meet the demand of ISO 13485 for CE marking in Europe by the notified body.

For more information, please refer to :

How to use ISO 13485 to get your devices approved for CE Marking
https://advisera.com/13485academy/blog/2017/10/12/how-to-use-iso-13485-to-get-your-devices-approved-for-ce-marking/

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Nov 08, 2018

Nov 08, 2018

Suggested Topics
Guest user Created:   Jun 15, 2026 ISO 13485 & EU MDR
Replies: 1
0 0

Templates: Technical Documentation for Medical Device & CER
Guest user Created:   May 07, 2026 ISO 13485 & EU MDR
Replies: 1
0 1

The risks of losing the ISO 13485 Accreditation
Guest user Created:   Apr 08, 2026 ISO 13485 & EU MDR
Replies: 1
0 1

ISO 13485 - Quality agreement for subcontractor

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.