ISO 13485 vs. GMP - Is there a difference between ISO 13485 and GMP?

[sleepzo]

Hi,

I'm wondering if there's a difference between ISO 13485 and GMP? And is there a good website, blog or book that has this information?

Thanks!

 

[howste]

Re: ISO 13485 vs GMP

Welcome to the Cove, Sleepzo!

Yes, there's a difference. Take a look at this comparison I posted in another thread a while back:
820 - ISO 13485-2003 Comparison Matrix.pdf

As far as websites, you're already at the best one I've come across...

 

[sleepzo]

Re: ISO 13485 vs GMP

Thanks very very much. That was so helpful!

 

[rudolfrm]

Hey, can you help me frends?
I have a question, what is the standar for GMP who applies for ISO 13485?

 

[Kales Veggie]

In short: They are independent standards.

ISO 13485- international recognized standard.

Country specific standards examples:

FDA 21CFR 820 (GMP for medical device) - USA
CAMDAS - Canada

 

[rudolfrm]

Thank you

Do you know if there is a GMP standard who applies for medical devices manufactures for example:
We make the medical gas feedings
medical feeding conections
medical air compressor
medical emergency alarm

Regards

Rodo

 

[howste]

In the US, the FDA regulations for medical devices (21 CFR part 820) are generally referred to as the GMP or Good Manufacturing Practices. The regulations that apply to your medical devices will depend on which countries your product is being sold/used in.

 

[judycohen]

Re: ISO 13485 vs GMP

I am unable to open this do you have another version?

 

[Ronen E]

Re: ISO 13485 vs GMP

I am unable to open this do you have another version?

Hi,

If you refer to the attachment in post #2 above - I just tried it and it worked fine for me (download and open). Not sure what the problem is at your end.

Ronen.

 

[Juzaili]

thanks 4 the information..
your explanation very clear. TQ.