What even is RAQA? Why Should I Care About Four Silly Letters?
RAQA is an acronym that stands for everything the leanTeam does for our clients:- Regulatory – Affairs
- Quality – Assurance
What even is RAQA? Why Should I Care About Four Silly Letters?
RAQA is an acronym that stands for everything the leanTeam does for our clients:
- Regulatory – Affairs
- Quality – Assurance
If you want to bring a medical device to market, whether you are working with the United States FDA or the European Union Medical Device Regulation, there’s no getting around these four “silly” letters. So now you have two options: pour over books and online articles to try to learn everything you can for yourself, or hire a team of experts who know it all and have even written a few books of their own (Hint: It’s leanRAQA. We are your RAQA dream team).
Why Is Regulatory Strategy Important?
Many medical device companies see “everything regulatory affairs” as a burden. That’s a matter of perspective.
The leanRAQA team sees regulatory strategy – done right – as a competitive advantage. So do our clients.
Are there lots of forms and confusing/changing regulations? Sure, and the leanRAQA team is here to help you navigate that process.
The thinking, the planning, and the strategizing for your business? That’s very much worth your time and your talents.
Engaging a team who lives regulatory affairs all day long, and EVEN enjoys it, will take the “burden” off and make you much more effective.
Do You Have Any Questions?
Project work varies greatly around here at leanRAQA.
Some clients “just have a question.” They “just like knowing they can call us” whenever the need arises. Others have an audit in two weeks – YIKES!!
The reason for your visit to our site today (thank you!) probably falls somewhere between a question and a crisis.
You’re looking for something specific – info on FDA product codes, perhaps? – and chances are I have it.
Don’t just scroll aimlessly (although the new website IS pretty cool). Put some time on my calendar and we’ll chat.
Regulatory + Strategy = Market Success
A strong regulatory strategy can be a huge competitive advantage, but not every company thinks that way.
But here’s a little insider secret – listen closely now.
The successful ones do.
So, if you’ve got a question about regulatory strategy, just ask us already.
I won’t put you on a big, impersonal mailing list and sell you all the time. You don’t have time for that, and neither do we.
Why Do You Need A Strong Regulatory Strategy?
First, you’re going to do regulatory affairs anyway – it’s unavoidable.
So if you’re doing it anyway, do it smartly, and with a qualified regulatory affairs and quality assurance team – like us.
Do it smartly and in the least burdensome way, and just maybe beat the competition while you’re at it.
SECOND, A STRONG REGULATORY STRATEGY LETS YOU:
Get money
Investors like knowing what they’re investing in.
If you can’t clearly articulate the intended use of your product, investors will smile politely but keep their checkbooks closed.
If you can’t accurately and effectively present the anticipated project costs, timelines, and testing, investors will still nod in all the right places.
But in the end, they’ll take their capital to a startup that can answer all their questions.
Sorry about that.
Skip the ditch
Come to Arizona, buy me a glass of tequila, and I’ll tell you about the clients who should have called me sooner.
The same ones who got caught out of compliance, and are already deep in a regulatory ditch.
I can help you out of that ditch, sure.
But you’re going to need a backhoe to fill the hole and a landscaper to cover it up.
And all that could have been avoided with a qualified RAQA team. Just sayin’.
Expedite clearance
Without a strong regulatory strategy, your FDA submissions risk getting sucked into a bureaucratic vortex.
You’ll end up wasting valuable time going back and forth with the FDA and other notified bodies, tweaking an intended use statement here, revising a quality document there.
And each and every edit adds time to your launch plan, pushing your timeline back further and further.
You can’t afford to waste that much time, now can you?
Contents Of A Strong Regulatory Strategy
You’ll see. It isn’t so bad. And I can help you with each.
- Clear intended use and indications statement
- Product type determination
- Product code determination
- Product FDA classification
- Potential Predicates Identified (for most devices)
- Identification of any exemptions
- Itemization of applicable recognized consensus standards
- Itemization of applicable FDA and other notified bodies guidance documents
- Analysis, costs, risks and recommendation for submission options
- Analysis and recommendation for test strategies based on standards and guidance documents
- Review of changing FDA regulations, policies, or politics that may affect product clearance
- Quality Management System requirements, costs, and resources post commercialization
Help Has Arrived!
Pick an open half hour on the calendar. Maybe we can lighten your workload and we would LOVE to help!
Regulatory Strategy Got You Stumped?
Don’t let the RAQA of it all stop you from bringing your medical device successfully to market.
Download my FREE Business Market Assessment tool which walks you through the revenue vs. cost modeling calculations that can help you judge the market viability of your product – before you commit.
Then pick an open half hour on my calendar and we can chat about the best submission strategy for your product.
