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Dear Sir,
FDA part 820 talk has the requirement on the control of "manufacturing material" that has adverse effect on the medical devices. May i know what are the minimum controls that normally practice by orthopedics medical device manufacturers that can still comply to regulation? Below are some controls that we are practicing now:
Do you think this is sufficient?
There are some gaps in our system, for example not all manufacturing materials are subjected to receiving inspection, some manufacturing materials are not always purchase from the same approved supplier etc. These manufacturing materials normally are off-the-shelf materials like polishing consumables, do you think this is a problem?
Please share the industrial practice. Thank you.
FDA part 820 talk has the requirement on the control of "manufacturing material" that has adverse effect on the medical devices. May i know what are the minimum controls that normally practice by orthopedics medical device manufacturers that can still comply to regulation? Below are some controls that we are practicing now:
- Only use manufacturing material approved by customer.
- Only purchase manufacturing material from customer approved suppliers.
- Only purchase the manufacturing material from approved suppliers.
- Only purchase approved manufacturing material.
- Conduct receiving inspection for manufacturing materials.
- Only use accepted manufacturing material for manufacturing processes.
- Conduct internal audit to confirm the compliance of the above.
Do you think this is sufficient?
There are some gaps in our system, for example not all manufacturing materials are subjected to receiving inspection, some manufacturing materials are not always purchase from the same approved supplier etc. These manufacturing materials normally are off-the-shelf materials like polishing consumables, do you think this is a problem?
Please share the industrial practice. Thank you.