Is anyone here using APQP (AIAG manual) in Medical Devices?

[Elzbieta]

Is somebody using APQP (AIAG manual) in Medical Devices?

 

[Stijloor]

Is somebody using APQP (AIAG manual) in Medical Devices?

If yes, what would your question(s) be?

Stijloor.

 

[Roberticus]

Is somebody using APQP (AIAG manual) in Medical Devices?

Actually, upon being selected for my current role as a Q.E. about 12 months ago, my Company sent me to Southfield, MI for a How-To course! If you offer up a more specific question as suggested above, I'll offer any insights I may have. While an interesting introduction to how prototyping and product launch are performed by TS 16949 companies, to date the most concrete application of the course matter has been that of material related to the PFMEA process, here at this newly ISO 13485ed contract manufacturer of Class I devices from whence I respond . . .

 

[Ronen E]

Is somebody using APQP (AIAG manual) in Medical Devices?

Hello and welcome to the cove

I'm not too familiar with APQP, but wouldn't it overlap with ISO 13485 / QSR Design Controls (21 CFR 820.30)?

Cheers,
Ronen.

 

[JaxQC]

The short answer is Yes but they don’t know it yet. After years doing PPAPs in automotive and now in medical, what medical aspires to & the level of control they want over their process / product… it’s the same info as the AIAG Blue Books.
The questions of the top OEMs and what they are trying to duplicate in their processes are the same. Some are re-inventing the wheel while others are catching on and getting a head start. I’ve been incorporating it in as we go at a Tier 1 and have yet to have one of our “new” control methods not exceed what they are looking for.