No design history file or device master record

racglobal

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#1
I have a couple of QMS documentation questions in a grey area and I was hoping to get some opinions on this.

A company has been developing a device over the years but without a QMS so there is no design history file or device master record to speak of. Please note this is a device startup. It went through clinical testing under an investigational authorization which does not require a QMS. Years later in 2019, they would like to start writing the DHF documents for this device and would like to integrate the DHF into the QMS. There are two questions:

1. The company would now like to make changes to the design and start working toward a commercial prototype. Does it make sense to bring the original investigational version into the QMS or writing the DHF retroactively and implement in the QMS? Or does it make sense to to start documenting the new version for the commercial type? And in parallel, keep the original clinical investigational device design history and manufacturing out of the QMS?

2. Here is a wrinkle. The company would like to eventually complete a regulatory submission but the submission will be based on clinical data collected from the clinical investigational device. In this case, presumably, the DHF should come from the original investigational device. Can this clinical data be also used to support regulatory submission of the modified device? The commercial prototype for which they would like to document in the QMS is very similar to the clinical invest. device but with some design changes.

I look forward to your insights. Thanks so much.
 
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Ronen E

Problem Solver
Moderator
#4
In that case my response is that apparently your employer needs to engage someone experienced to walk you through or at least set-up a viable strategy to get you started in the right direction. It's a complex of issues, not some straightforward question(s) suitable for being answered effectively on a public forum by people you know very little about.

Disclosure: I see myself as such a person. I don't intend the above as advertisement, I just think that you are taking a risky path.
 
#6
Is the existing clinical data considered your design validation?

If yes, you must retroactively create the entire design history file for that device. This means you must go back and do all required design verification tests along with many other things.
If no, you can include all the information on the device, including clinical data, in your earlier phases of the design history file for the new iteration. These records will be used to support the design decisions for the new product, and you will do design verification and design validation (new clinical study) in that order.

Some notes: I don't know what device you are talking about, so I don't know if a clinical study is required for validation. I don't know the differences between the old and new devices, so I don't know if the old clinical data would apply to the new. I don't know why type of clinical study was done and whether that study would be sufficient for commercial approval. I also don't know to which regulatory body you are referring.

Conclusion: I agree with Ronan. Get some help.
 
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