3D Scanner Software validation

[MJB_Devices]

Hello!!!
We are using a 3D scanner to scan the patient's head to create a 3D printed model of the helmet. The exact same scanner has been validated and cleared for use in the PREDICATE device for the same indication. Is it still necessary to validate (IQ, OQ, PQ) and evaluate (accuracy, repeatability, reproducibility) the scanner software when it has already been cleared on the predicate device for the same indication?

I would appreciate any help or guidance you can provide.

Thank you!!

 

[Tidge]

While folks do use the terms IQ/OQ/PQ when discussing "software", I would not use them in this context... for several reasons, including:

1. Strictly speaking: IQ/OQ/PQ only have commonly accepted meaning (especially in the medical device industry) in the context of process validations
2. When adapted for Non-Product Software validations, there is very poor alignment with the meaning of the terms for process validations (I watch people try to make it work, but it is ugly)
3. The consensus standard for medical device software is 62304, which does not even hint that IQ/OQ/PQ is meaningful.

If you are asking about submissions, you will need to consider the markets, for example for the USA see here.

 

[Junn1992]

The exact same scanner has been validated and cleared for use in the PREDICATE device

So are you saying your device is a combination of a marketed product + some parts manufactured by your company?

 

[MJB_Devices]

So are you saying your device is a combination of a marketed product + some parts manufactured by your company?

The scanner and the printer are a part of the process flow that is necessary to produce the final product. Health care professionals will create digital images of patients' heads by scanning their heads. These images are then processed by the 3D printer software to create the helmet.

 

[Jim Wynne]

Anyone who would allow themselves to be scanned by a device with unvalidated software should have their head examined.

 

[Cari Spears]

^LOL

 

[MJB_Devices]

Anyone who would allow themselves to be scanned by a device with unvalidated software should have their head examined.

That's a good one. However, the exact same scanner has been validated and cleared for use in the PREDICATE device for the same indication.

 

[Junn1992]

Hmm...

So marketed product A gets used as part of a medical device system B.

Can the manufacturer of B assume that A works fine 100%? Seems like part of a purchasing process to me that requires proper incoming verification and validation.