They also mirror nearly exactly the situations uncovered by the US Department of Defense, when they did similar audits of aerospace firms and found rampant quality system problems among so-called certified firms. After being alerted to the CR Bard scandal which we reported on earlier today, I took some time to look over the FDA’s warning letter database, and the findings are just about as horrifying as you’d imagine.

These can eventually lead to criminal charges, so are not to be taken lightly. In the USA, the medical device scheme is managed by the Food and Drug Administration (FDA), which then issues “warning letters” to companies found in violation. I’m plugged into that network now, so will be adding some Oxebridge energy to the push for reform in that arena, too. While Oxebridge has been largely fixated on ISO 9001 violations and aerospace scandals involving AS9100 certified firms, a handful of others have been working the medical device angle.

The failings of the IAF accreditation scheme, led largely by the accreditation bodies ANAB (USA), UKAS (UK) and SCC (Canada), are becoming more and more visible, prompted by reporting by not only this website, but others hoping to call government attention to the risks the scheme poses to human life.

Iso 13485 fda