Exclusion of Design and Development Controls - ISO 13485 Section 1.2

[quest]

Section 1.2 states 'If regulatory requirements permit exclusions of design and development controls, this can be used as justification for their exclusion from the quality management system.'

Can someone give me an example of a regulatory requirement that would, according to ISO 14969, 'permit organizations to place some medical devices on the market without having to demonstrate conformance with design and development controls'?

Our auditor has indicated that we can use this exclusion but I need to be able to justify the exclusion!

We manufacture class I and II medical devices.

 

[DannyK]

Re: ISO 13485 Section 1.2 Application

The one that is the most common is with companies registered with Canadian Medical Device Regulations.

If your device is class II (Canadian classification), you can exclude design.

Danny

 

[Marc]

ANSI/AAMI/ISO 14969 Summary description

ANSI/AAMI/ISO 14969 Summary description:

ANSI/AAMI/ISO 14969
Quality Systems -- Medical devices -- Guidance on the application of ISO 13485 and ISO 13488
Edition: 1.0
Association for the Advancement of Medical Instrumentation/International Org. for Standardization
01-Jan-1999
30 pages

 

[Doug Tropf]

As are a contract sterilizer of medical devices, certified to 13485, we excluded design and control.

 

[quest]

Thank you for your replies.

I have read 14969 and its guidance for 13485 section 1.2.

Our auditor has already advised me that we can excluded design and development from our quality system for our CMDCAS/13485 compliance. My problem is how to justify its exclusion.

It sounds like the Canadian Regulations might be the answer. Where in the regulations is this allowed exclusion stated or inferred?

 

[quest]

Sorry about the questions. I was able to find some links on this site that discussed the same issues I am having. Now that I have read more, I believe that our assessor was incorrect to say we can exclude design and development.

The product he performs a CE audit on is purchased from an outside source who is repsonsible for the d and d of the product. We perform all other quality system requirements and do have a technical agreement with them.

The remainder of our products, and the bulk or our business, is classified as I in the EU and II in Canada. We are responsible for the D and d of these products.

If I read 14969 correct, we can take the exclusion on the one product that is purchased. My question remains though, what do I state as justification for the exclusion?

Sorry I wasted any ones time before I gathered more facts.

 

[Al Rosen]

Sorry about the questions. I was able to find some links on this site that discussed the same issues I am having. Now that I have read more, I believe that our assessor was incorrect to say we can exclude design and development.

The product he performs a CE audit on is purchased from an outside source who is repsonsible for the d and d of the product. We perform all other quality system requirements and do have a technical agreement with them.

The remainder of our products, and the bulk or our business, is classified as I in the EU and II in Canada. We are responsible for the D and d of these products.

If I read 14969 correct, we can take the exclusion on the one product that is purchased. My question remains though, what do I state as justification for the exclusion?

Sorry I wasted any ones time before I gathered more facts.

You can't take an exclusion for one product. What you can do is address the issue in your Quality Manual or procedures. I know that the next thing you will ask is how? The answer to that is determined by what the product is. In other words, we need more information.