Management representative in ISO 13485

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:

• How to define roles and responsibilities within an ISO 13485-based QMS https://advisera.com/13485academy/blog/2017/11/16/how-to-define-roles-and-responsibilities-within-an-iso-13485-based-qms/
• How to fulfill management responsibilities in ISO 13485:2016 https://advisera.com/13485academy/knowledgebase/how-to-fulfill-management-responsibilities-in-iso-13485/