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Management representative in ISO 13485

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Guest user Created:   Feb 15, 2021 Last commented:   Feb 16, 2021

Management representative in ISO 13485

Hi! We are wondering about the management representative in ISO 13485. We do not have this competence in house, is it possible to outsource that resposibility, or does it have to be a person in the management team?

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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 Feb 16, 2021

Yes, you can outsource a person as a management representative. A management representative should be someone who is knowledgeable, trained, and have experience in dealing with the Quality Management System according to ISO 13485 of the company as well as familiar. Also, it would be preferable that that person has experience with your type of medical devices and technologies. This person must be available upon your request.

With an outsourced Management representative, you need to have a contract where mutual obligations will be defined.

For more information, please see the following articles:

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