Expert Advice Community

Home / ISO 13485 & EU MDR / Gxp versus 13485

Guest

Gxp versus 13485

ISO 13485 & EU MDR
  Quote
Guest
Guest user Created:   Nov 10, 2022 Last commented:   Nov 10, 2022

Gxp versus 13485

ISO 13485 & EU MDR

I am working an a pharma company with haveing a some combination products - medical device with pharma. We want to have in addition to GxP System the 13485.
Could we implent the 13485 with a mixture of good running GxP SOP (e.g. change control) and new ISO SOP?s

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 Nov 10, 2022

Yes of course that you can.

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Nov 10, 2022

Nov 10, 2022

Suggested Topics
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
lynda Created:   Mar 25, 2026 ISO 13485 & EU MDR
Replies: 1
0 0

ISO 13485 Compliance for Medical Device Stamping Process

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.