Control of R&D (Research and Development) Parts and Equipment


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I have a few questions pertaining to the control over R&D parts/equipment.

Currently, we state in our Design Control procedure that units built for V&V must use the intended manufacturing processes and should have DHRs. We'd like to not require part inventory and lot histories before V&V. Is this acceptable and why?

For suppliers who provide us with R&D parts do they have to be on the approved supplier list if those parts won't be part of design V&V?

Basically, how much control over equipment is required if not used for design V&V or assessing quality of finished devices?

Any assistance/feedback would be most appreciated.



Super Moderator
Might be helpful if we split up R and D. On the research side - which it sounds like maybe you're talking about - the only controls are up to you. If you're really into design, for what purpose are you building the items (and purchasing parts, etc.)?


Involved In Discussions
The purpose of building items is for R&D to determine feasibility and compatibility. Is it a regulatory requirement that we control R&D equipment? As previously stated, we'd continue to control any equipment used for design verification and validation.

Thank you.


Quite Involved in Discussions
I agree with yodon. Especially if you are talking about medical devices to be approved / cleared by FDA, "R" and "D" are two completely different worlds.

FDA does not regulate research, but it certainly does have something to say about design.

I think it is up to your company to have a procedure in place to decide when a research project has resulted in the recognition that a device is to be developed. Once that decision is made, design controls apply, but not before.
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