Purchasing for Design and Development Organization

[sriramsl]

Dear all

Request a help from experts.

A company which is involved only in Design and Development of Medical devices for its clients, do not perform Manufacturing, do they have to comply to 7.4 Purchasing for components to be purchased for D&D activity?

I am of the opinion, it is not necessary as D&D is a Research activity and may have to purchase all kinds of parts from different sources for "trial" purpose and practiccally following the 7.4.1 and 7.4.2 will be impractical.

Moreover the Standard under 7.3 does not mention the requirement. However 7.4 mentions as "organisation" in which case it may be applicable.

Additionally can such an organisation can declare 7.4 as non-applicable?

Regards
Sriram

 

[somashekar]

Dear all

Request a help from experts.

A company which is involved only in Design and Development of Medical devices for its clients, do not perform Manufacturing, do they have to comply to 7.4 Purchasing for components to be purchased for D&D activity?

I am of the opinion, it is not necessary as D&D is a Research activity and may have to purchase all kinds of parts from different sources for "trial" purpose and practiccally following the 7.4.1 and 7.4.2 will be impractical.

Moreover the Standard under 7.3 does not mention the requirement. However 7.4 mentions as "organisation" in which case it may be applicable.

Additionally can such an organisation can declare 7.4 as non-applicable?

Regards
Sriram

Hi Sriram ...
I think that the 7.4 and more so the 7.4.1 will apply to the extent of determining the criteria, considering both the D&D organization as well as the type and extent of agreement with clients. Hence the criteria will vary and must be applied with justification.
As far as the 7.4.2 is concerned, very important deliverables of the D&D organization to the clients gets addressed and I believe this is a very practical, but to be addressed in the procedure appropriately.
Adding further, when I see the word 'components', I guess its referring to electronic medical device D&D activities, and as such many regulatory inputs perhaps is coming from the clients about the safety requirements, where in the 7.4.2 inputs become very crucial, and the same is further incorporated into the D&D outputs.
Hence for me the 7.4 is applicable .....

 

[yodon]

We're a (contract) D/D company registered to 13485 and the clause is applicable to us. The primary reason is for purchasing calibration services (we do a lot of V&V work and need calibrated equipment for it). We purchase parts to make prototypes and such and address it in our QMS but it's very minimal (all parts are commercially available and verification is just confirmation that the delivered material is what we ordered - we keep the packing slips). We also purchase software libraries. Again, very minimal approach to 7.4 but these DO go into the final product.

Bear in mind that you take a risk based approach to this (and other) clauses. The level of control is commensurate with the risk. Calibration, in our case, poses the highest risk so that's where we apply the most control.

 

[Mark Meer]

...
I am of the opinion, it is not necessary as D&D is a Research activity and may have to purchase all kinds of parts from different sources for "trial" purpose and practiccally following the 7.4.1 and 7.4.2 will be impractical.
...

I agree that at the stage of development you are describing, these are impractical. But at later stages, control of materials becomes integral to the design.

Do you output a bill of materials? Do you carry out / arrange product testing, or design verification/validation activities? If so, how can you purport to have a controlled design if you are not controlling the parts/materials that go into it?

Ultimately, it would depend on your arrangement with your customer. If all they want are the design outputs drawings - at which point they would source suppliers, develop a controlled manufacturing process, and conduct the design V&V - then maybe you could argue these are not applicable. If, on the other hand, they expect you to hand over a controlled, verified and validated design, then purchasing controls would be part of that.