B
Hi Everyone,
I am currently working on implementing CFR 820 regulations for a medical device company.
We are ISO 9001 and 13485 compliant but I am trying to make sure we cover all regulatory requirements.
Do we need to have comprehensive forms and procedures for Adverse Events and product recalls?
Wasn't clear from these sections:
Section 15. Complaints
Includes MDR reporting but not much on recall requirements.
Section 12. Product Evaluation
Mentions Non conforming product and failure Investigation.
Not sure if the other CFR codes detailing recall procedures are relevant here?
Recalls, Corrections and Removals (Devices)
21 cfr 7 for example
cheers,
Bobbyv
I am currently working on implementing CFR 820 regulations for a medical device company.
We are ISO 9001 and 13485 compliant but I am trying to make sure we cover all regulatory requirements.
Do we need to have comprehensive forms and procedures for Adverse Events and product recalls?
Wasn't clear from these sections:
Section 15. Complaints
Includes MDR reporting but not much on recall requirements.
Section 12. Product Evaluation
Mentions Non conforming product and failure Investigation.
Not sure if the other CFR codes detailing recall procedures are relevant here?
Recalls, Corrections and Removals (Devices)
21 cfr 7 for example
cheers,
Bobbyv
