3D printer validation

[MedDev12]

Hello,

Our company uses a Stratasys F170 3D printer for mold manufacturing for a medical device company. We are looking for the best validation methods to ensure that the molds produced meet the required specifications.

We understand that the printer has its own built-in calibration system, but are there additional cost-effective methods to validate 3D-printed molds without relying on expensive quality control tools?

We have researched some validation tools, such as hand scanners, but they appear to be unreliable, while other advanced measurement systems are quite costly.

Key Questions:​

1. What are the best validation methods for 3D printers in medical device manufacturing?
2. How can we ensure that the molds meet the required specifications effectively?
3. Aside from the printer’s built-in calibration system, what other reliable and affordable validation methods can we use?
4. How can we justify relying on the printer’s built-in calibration to ensure accuracy and consistency?

For context, the medical device we manufacture requires precise customization, similar to 3D-printed surgical guides or dental prosthetics.

Any insights or recommendations would be greatly appreciated.

Thank you!

 

[Jen Kirley]

Hello MedDev12,

I will refer you to ASME's paper Process Verification & Validation for Medical Devices Using Additive Manufacturing which does address 3D printing. Since I don't know details about the parts produced or the process itself, I will stop here with the attachment and let you see how much it does to address your questions.

I hope this helps.

 

[Naneki]

IQ/OQ/PQ should be the validation processes.