What is Quality Systems Compliance? Why Do I Need a Quality Management System?
Quality System Compliance is set in place to ensure industry standards are met. Your medical device will not make it to market if it doesn’t meet quality systems compliance, so you will need a quality management system to ensure it does. Sure, you could try to represent yourself, so to speak, and learn everything there is to know about regulatory affairs and quality assurance… or you could focus your energy on integral aspects of your business that matter most to you, and hire leanRAQA to focus on the aspects that matter most to us.
Make Quality Make Sense®
leanRAQA earned its name because we 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 Make Quality Make Sense® together.
We’ll give you the quality management system (QMS) you need – no more, no less.
And we’ll help you see how quality can be a competitive advantage.
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 quality management system – it’s a living, breathing, use-it-every-day system. That’s right to demonstrate compliance you need to actually use those scary looking procedures. Don’t worry, leanRAQA has your back. We know the compliance checklist and aren’t afraid to add (or remove) tasks as needed:
- Management Review
- Internal Audit
- Supplier performance (and qualification)
- Labeling
- UDI
- Complaint
- Reportable Events
- and all the little things to maintain your design files
And just when you’ve got “maintaining” under control, – look over there! It’s a changing regulation!
No sweat. We’re buds now, so leanRAQA can study the new regulations, guidance documents, and standards for you. Then, we can create transition and implementation plans on your behalf.
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
- MDSAP
…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 medical 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 systems compliance needs.
