Do 21 CFR 820 Requirements need to be considered when deploying ISO 13485 in the UK

L

lennon121

Dear all,

At what point must you follow 21 CFR 820 Requirements when deploying ISO 13485? We are a medical device company in the UK.
 
M

MIREGMGR

Re: Do 21 CFR 820 Requirements need to be considered when deploying ISO 13485 in the

The question is a bit too open-ended, but guessing as to the intended meaning:

A UK device manufacturer might want to have a combined QS and product regulatory stance (US FDA QSR + ISO 13485 + MDD) in order to be able to effectively market in the US and those other countries that do not have their own device regulatory system, and most readily accept US FDA marketing approval as an indicator of legal device importability.
 
L

lennon121

Re: Do 21 CFR 820 Requirements need to be considered when deploying ISO 13485 in the

So if you have no intension of supplying or seloling in the US market then 21 CFR 820 does not need to be followed?
 
G

Graz94

Re: Do 21 CFR 820 Requirements need to be considered when deploying ISO 13485 in the

Do you export your device to the US?
 
L

lennon121

Re: Do 21 CFR 820 Requirements need to be considered when deploying ISO 13485 in the

No, the UK and other europeon countries!
 
G

Graz94

Re: Do 21 CFR 820 Requirements need to be considered when deploying ISO 13485 in the

You don't need to worry about 820 until you do.
 
L

lennon121

Re: Do 21 CFR 820 Requirements need to be considered when deploying ISO 13485 in the

Thank you Graz94, do you have much expertise in 21 CFR 820?
 
G

Graz94

Re: Do 21 CFR 820 Requirements need to be considered when deploying ISO 13485 in the

Yes, our company have been through seval FDA audits and I have deployed the Quality system for our EU and US HQ's.

There is a nice matrix on here somewhere that links the clauses of each QMS.

It is pretty helpful, I'll have a look and see if I can find the link.
 
L

lennon121

Re: Do 21 CFR 820 Requirements need to be considered when deploying ISO 13485 in the

We were pulled up during a gap analysis audit of 13485 - FDA requirements the other day as our change control system for the change of documentation doesn't consider the customer, regulatory or technical files, can you tell me where the requirement in 21 CFR 820 is for this?
 
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