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Compliance with ISO 13485 or GMP for Class III device
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.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
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/
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Nov 08, 2018
Nov 08, 2018
Nov 08, 2018