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Hello everyone,
I have a client who wants me to fill the role of Management Representative (MR) at their 2-person device company. I know that ISO 13485 registrars have stated that the MR must be an employee of the company and not an external consultant. But my client is not interested in ISO certification.
I have not been able to find where the FDA has made a definitive statement one way or the other. Has anyone out there ever used an external party as MR and then been audited by the FDA? If so, what was the FDA's position?
Thanks for any guidance you can offer,
Laura
I have a client who wants me to fill the role of Management Representative (MR) at their 2-person device company. I know that ISO 13485 registrars have stated that the MR must be an employee of the company and not an external consultant. But my client is not interested in ISO certification.
I have not been able to find where the FDA has made a definitive statement one way or the other. Has anyone out there ever used an external party as MR and then been audited by the FDA? If so, what was the FDA's position?
Thanks for any guidance you can offer,
Laura


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