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Hi,
I have just assumed the Quality Assurance manager at my company. We purchase most of our medical devices (mostly class I devices) from a sister company which completes a thorough inspection. Would a strongly worded certificate of compliance from the sister company exempt our company from inspection of devices received while still maintaining compliance with FDA 21 CFR 820?
Thanks for your help in this matter.
I have just assumed the Quality Assurance manager at my company. We purchase most of our medical devices (mostly class I devices) from a sister company which completes a thorough inspection. Would a strongly worded certificate of compliance from the sister company exempt our company from inspection of devices received while still maintaining compliance with FDA 21 CFR 820?
Thanks for your help in this matter.
