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?
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: