Not quite the Dostoevsky title; close maybe?  I’ve had the pleasure twice in my career to have a government regulation created specifically for me.  Note that I’m very careful to follow government regulations to the letter and I’m high on full compliance with quality standards.  I do read the regulations carefully, though, and am happy to create technology solutions that comply with the regulations and provide creative, cost-efficient, and efficiency-maximizing technology.

The first time I had a regulation created specifically for me was with the FDA.  The 510k regulations on medical devices and software at the time did not require that software developed solely for in-house use be 510k certified.  I created a validated solution that helped use provide the highest level of safety, auditable quality, and greatly improve efficiency.   But I did not get a 510k pre-clearance or certification from the FDA because it was not required.  Long story short, we were audited by the FDA and they issued a preliminary finding that I should have sought 510k pre-clearance and certification for the software.

I happily pointed our auditor to the exact language that exempted us from the 510k requirements.  The FDA withdrew the finding and over the next year issued a new regulation that required 510k pre-clearance for in-house developed software. I was fortunate to have an outstanding Director of Quality (thanks Gina!) and we received 510k pre-clearance for the software shortly after the FDA withdrew their finding.  When the FDA finalized the new regulations and returned for an out-of-cycle audit, we had already fully complied with the new regulations.  Over my career I have worked with many outstanding Quality leaders and I am very appreciative and grateful for their support.

I’ll add a post on my second experience soon.

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