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

[tebusse]

Greetings,

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.

Tonia

 

[yodon]

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.)?

 

[tebusse]

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.

 

[JeantheBigone]

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.