Expert Advice Community

Guest

Facilitating training of medical devices organization for their management

  Quote
Guest
Guest user Created:   Nov 22, 2021 Last commented:   Nov 23, 2021

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?
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 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.  
 

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Nov 22, 2021

Nov 23, 2021