Let’s Get Small
I named my company leanRAQA because I believe smaller is better.
And while quality systems aren’t one-size-fits-all, the leaner they are, 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-it-every-day system.
And just when 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 can create transition and implementation plans on your behalf.
You can breathe easy – we’ve got your back.
Take a deep breath – and dive in.
A good Quality Management System is not a once-and-done deal. It lives.
It breathes. It needs constant tending.
It’s imperative you select the best one for you. Or better yet, let’s build one to your exact specifications.
Start with our template. It has 80 percent of what you need. Then, we pair you with a dedicated leanRAQA team member to customize it to your business.
It’s okay to ask for help. It’s why we’re here.
Let’s at least talk about it. No commitment, just advice.
Have quality, will travel
All regulations are welcome here!
Whether you’re more of a ’21 CFR 820′ kinda person or you dabble in the Eastern European and Health Canadian arts, we can:
- MDR 2017/745
- SOR 98-282
- ISO 13485:2016
…with the best of them.
So if you’re already there, or you’re ready to expand, so are we.
You Can’t Outsource Quality
The buck stops with YOU, even if another company is designing and distributing your device.
So download my 21 CFR 820 Roles and Responsibilities Guide to see who is responsible for what.
Then pick an open half hour on my calendar and we’ll chat about your quality management needs.