Translating from Automotive to Medical Device industry - [email protected]

[Ekaekto]

Hi everyone,

I am working at a supplier that focuses heavily on automotive, while also manufacturing some things for the medical device industry.

I am currently working on a QAA and needing to translate the term [email protected] (2 day production) into medical device terms. I have little experience with regulatory speak in the automotive field, and am unsure what the correct translation into medical speak is.

Thanks so much for your help.

 

[Miner]

I am not in the medical device field, but I believe that run at rate is an aspect of what is called Performance Qualification (PQ). However, PQ may require more than just 2 days production.

 

[Ekaekto]

Thanks so much for your reply, I will check into performance qualification and see if I find some relevant terms. I'm aware that more than 2 days production is necessary, its just one of the vetting processes we have for our production as well as subcontractors to see whether they are able to produce at the neccessary rate - thanks for the heads up