Let’s Get Small
I named my company Lean because I believe smaller is better. And while quality systems aren’t one-size-fits-all, the leaner, the less burdensome, which is better for you and your governing bodies.
So “let’s get small” together and give you the quality management system (QMS) you need.
No more, no less.
Yay, my product is cleared.
The hard part is done!
Alas, no. The contrary is true.
We’ve got to assess, implement, and maintain a compliant QMS – it’s a living, breathing, use-every-day system.
And once you’ve got “maintaining” under control, look over there! It’s a changing regulation!
No sweat. We’re buds now, so we can study the new regulations, guidance documents, and standards for you. Then, we’re ready to create transition and implementation plans on your behalf.
Our friendship will come in super handy if anything unexpected happens. I’m talking the 483s, the warning letters, the ‘major non-conformities’ from a Notified Body.
Remediation to us is more than repairing quality system deficiencies.
It has to be.
We consider the underlying business system and company culture. That way, we can expedite resolution with the FDA, prevent recurrence, and improve your overall organizational health.
Have quality, will travel
All regulations are welcome here!
Whether you’re more of a ’21 CFR 820′ kinda guy or you dabble in the Eastern European and Health Canadian arts, we can MDR 2017/745, SOR 98-282, ISO 13485:2016, and MDSAP with the best of them.
So if you’re already there, or you’re ready to expand, so are we.
+ Michelle +