ISO 13485 for 3D Printing Services

[Thirsty Thursday]

Hello,
We are pursuing ISO 13485:2016 as a contract manufacturer of 3D printing medical parts. I am building our QMS with the terms "product" and "medical device" synonymous. Essentially, our QMS has everything in place to cover medical device requirements, but we are just a manufacturer of components for customers that make the medical devices and are not subject to FDA registration.

Is it common for related businesses to register with ISO 13485 or am I missing something?

Thanks,
Ryan

 

[LUFAN]

You don't need to manufacturer a finished medical device to achieve certification to ISO 13485. I made a post about this the other day: ISO13485 for Non-Device Medical Image Storage Software.

Product in ISO 13485 refers to the output of your product realization process and includes components and services.

 

[Ed Panek]

I agree with Lufan however in this case you supply parts to a medical device that OEM will impose quality requirements on their suppliers. In the USA FDA expects OEMs to control their suppliers within their regulations

 

[Thirsty Thursday]

Thank you for the clarification.