Crimson Audit & Review

Content Audit, Review & Consulting for Medical Device Makers

Jet Planes and Medical Devices: A Cautionary Tale

Posted by crimsonlanguage on 2011/09/30

From time to time, I’ve written and spoken about the connection between the aerospace and medical device industries. Historically, there has been a significant amount of congress between the two industries in terms of engineering and management talent. Both have a strong safety mandate because catatstrophic product failure has dire consequences for users. In fact, this is why we adopted and modified a standard from the aerospace industry (SAE J2450) as the basis for our resource testing, audit and QA activities. Today, it still stands as the only metric to recieve an official Notified Body endorsement.

I’ve also written in this blog about the dangers to the device industry of Chinese IP theft. Now, an avionics joint venture between GE and a Chinese firm is raising many of the same  questions for US avionics/aerospace technology…and it also highlights concerns for US medical device technology. If aerospace joint venture technology, with all it’s required firewalls, is potentially at risk, how much more device technology? Especially when SFDA technical file examination + scrutiny from 3 seperate Chinese testing houses is taken into consideration. This may be a the reason why GE recently transferred their entire imaging business to China…a simple acknowledgment of an impending reality.

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