Can I make an exclusion of Design and Development in ISO 13485:2016 if my product is not regulated

[kmuela]

Our product is media for the cell and gene therapy industry, and it is not regulated. Our customer requires us to become certified to ISO 13485:2016. Can we claim an exclusion to Design and Development?

 

[John Broomfield]

Where are the media specified?

Who specifies and validates the specification of the media?

 

[engemerson]

hello you can delete the item yes, as long as you don't have a product that is developed by you. (machining service is provided, for example, manufactures according to the drawing sent by your customer).
whether or not regulated, it needs a project and that it is within its QMS.

 

[kmuela]

Where are the media specified?

Who specifies and validates the specification of the media?

We have both stock and custom product. I am referring to our stock product, which we developed the specifications for.

 

[Sidney Vianna]

Our product is media for the cell and gene therapy industry, and it is not regulated. Our customer requires us to become certified to ISO 13485:2016. Can we claim an exclusion to Design and Development?

Absolutely not. You are design responsible, so you cannot justify an exclusion or non applicability of the product design process and still claim conformity with 13485.

 

[Ed Panek]

What Sydney said. This is a no brainer.

 

[kmuela]

Yeah, I know - I wanted verification from others because I was told by someone internal to my company that because we were not a device, and are not regulated overselves, we would not have to follow D&D - I was able to present data from the introduction section of the standard itself that almost convinced them.

 

[ED76]

We were in the same position, looking at the part in the intro that says you may exclude parts of 6,7, and 8 if they are not applicable. But if you are conducting D&D they are applicable. Our only exclusions are for servicing, sterile and implantable items. We use risk assessment to justify varying levels of control over for example reagents purchased for research purposes or for product manufacturing.

 

[LUFAN]

Our only exclusions are for servicing, sterile and implantable items. We use risk assessment to justify varying levels of control over for example reagents purchased for research purposes or for product manufacturing.

Just to clean up some language, only section 7.3 can be "Excluded", all other sections would be "Not Applicable." Make sure to reference it like that in your quality manual. I've seen findings be issued for that despite how ticky tack it is, it's explicitly stated in the document as quoted below.

“If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system.”

“If any requirement in Clauses 6, 7 or 8 of this International Standard is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system.”

 

[indubioush]

You do not design or manufacture a medical device, so complying with ISO 13485 does not quite make sense. You say your customer is requiring it. I would ask them why. The design and development section of the standard my be excluded because you do not design or manufacture a medical device. On the other hand, this section does not say design and development of a medical device, it says design and development of "product." Murky.
However, if you follow ISO 9001 (which makes more sense in my opinion), design and development does apply to you. Perhaps it makes sense to reach out to your supplier and see if they would accept a certification to ISO 9001.