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Facilitating training of medical devices organization for their management
My question is do I need to be certified to ISO 13485 to facilitate training of medical devices organization for their management since I have been a lead auditor and have great third party certification and implementation experience?
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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
Kristina Zvonar Brkić
Nov 23, 2021
A person who performs education about ISO 13485:2016 must have some proof that he/she understands all necessary requirements which are specific to the medical device manufacturer. This proof can be a certificate for the ISO 13485:2016 Lead auditor or experience with work in medical device manufacturers. ISO 13485:2016 has some specifics which can be seen only in that standard, therefore understanding and knowledge of ISO 13485 are necessary.
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Nov 22, 2021
Nov 23, 2021
Nov 23, 2021