evan_kim90
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Hi All,
I have a question regarding distributor control under MDR, ISO 13485, and MDSAP.
During a recent discussion with my auditor, it was mentioned that under MDR, distributors may need to be treated as critical suppliers. Could you please confirm if there is a specific regulatory section addressing this requirement?
Additionally, how do other standards like ISO 13485 and MDSAP view the control and management of distributors? I would appreciate any insights or practices on how you manage distributor relationships and compliance within your organizations.
Thanks in advance!
I have a question regarding distributor control under MDR, ISO 13485, and MDSAP.
During a recent discussion with my auditor, it was mentioned that under MDR, distributors may need to be treated as critical suppliers. Could you please confirm if there is a specific regulatory section addressing this requirement?
Additionally, how do other standards like ISO 13485 and MDSAP view the control and management of distributors? I would appreciate any insights or practices on how you manage distributor relationships and compliance within your organizations.
Thanks in advance!