I have an idea for a medical device! Now What?
Find a Qualified Medical Device Quality Assurance and Regulatory Compliance Team
It takes a village. If you have conceived a possible breakthrough medical device, or a new software as a medical device, you will need a qualified team. The right team will develop a regulatory strategy and medical device compliance plan to guide you through the necessary regulatory and quality steps for bringing your device to market. The FDA, EU MDR, notified bodies, 510(k) clearance, ISO 13485 certifications, 21 CFR 820 Compliance, ISO 14971 are a few of the terms you’ll become familiar with on the journey … the leanTeam are experts in handling every situation you may face (and warning you of which ones to expect).
Connect with leanRAQA for Your Project
Michelle has been helping raise medical device babies since 2010, so she and her team know what moves to make and what mistakes to avoid when it comes to regulatory and quality. Don’t waste your time trying to read through and decipher the “what to expect when you’re expecting” books alone. Do it with a team who knows so much, we’ve written a few helpful guidebooks of our own.
Regulatory Pathway Assessment Guide
17 pages of perhaps the most helpful guidelines I have ever created. It walks you through how to determine predicates, product codes and overall regulatory strategy. Now updated with EU MDR requirements!
Business Market Assessment Guide
A walkthrough of the revenue vs. cost modeling calculations that help you judge whether it makes financial sense to pursue your medical device in specific markets–before you jump fully in.
21 CFR 820 Roles / Responsibilities Guide
Who is responsible for complying with what regulations? You? A contract manufacturer? A design firm? What will medical device compliance look like for you? Find those answers with this handy guide.
Now you need a Regulatory Strategy
You’re ready to invest in your medical device and now you need to come up with the birth plan making it a reality. There is so much to consider. From FDA QMSR (Quality Management System Regulation) and QSR (Quality System Regulation) or EU MDR (Medical Device Regulation), you know your baby is regulated somehow. What do you actually need? That’s where the leanTeam comes in. Instead of trying to come up with the plan yourself, let us do the research. At the end of our assessment, we promise you won’t be left with your head scratching. We’ll identify what you need to market your device in bite-size steps to get you there.
The next steps are crucial, so get them done in a timely manner. The leanTeam can help keep you on the right timeline and won’t let you get sidetracked or lost.
Come Up with a Testing Strategy
Create a Budget for getting your Medical Device to FDA clearance
What’s the Timeline?
Without giving yourself a hard-and-fast timeline to get these things done, they could sit on the wayside for months or years, hindering your medical device from ever making it to market. Working with the leanRAQA team will help you stay on track with your regulatory and quality strategy and bring your medical device to market as quickly as possible.
I have a First Prototype for my Medical Device!
Good job making it this far! Now get ready for…
Securing your First Round of Investments to Fund your Medical Device
In order to secure funding, you need to be able to clearly articulate and communicate your regulatory strategy, everything from the intended use of your product to project costs, timelines, and testing. If you don’t know the right thing to say to investors, they will kindly smile, nod, and keep their checkbooks closed. The leanRAQA team is here to help you accurately and effectively communicate the intricacies of your medical device regulatory and quality plan to investors to help secure investment. Remember that regulatory strategy we discussed before? It could be pivotal in securing your funding.
Phase 1 QMS (Quality Management System) / Design Controls
Pre-Submission – Never heard of her!
We’ll help you navigate if a pre-submission is right for you and your device. If you don’t know what a pre-submission is, check out my Regulatory Submissions page for more information. Or just ask us when you put time on our calendar.
Production Equivalent Run
If you have made it this far without having your ducks in a row, the fees and rushed processes can be very expen$ive. Your other option is to build a time machine retrospectively, but this option can also be very, very expen$ive.
FDA clearance / Approval
Woo hoo! We’ve been cleared! But the work doesn’t stop there. Now we need…
A Full Quality Management System (QMS)
Think of the QMS as a way to keep your medical device baby safe (and those who interact with it) as it grows into a toddler, child, teenager and adult.
The First Production Run of Your Medical Device!
You have now successfully given birth to your idea that was once just a dream. But does the hard work stop when a baby is born? Absolutely not. The case is the same with your medical device baby. The leanRAQA team will be your Super Nanny and teach you everything you need to keep this baby safe within the market’s regulations as it grows into a well-rounded toddler.
First Sale!
You have a beautiful babe, and now your family (in this metaphor, the market) is proud of the work you have done and is happy to claim your child as one of their own. Now let’s give this kid everything they need to become a successful teenager. In other words, ensure your teenager is safe and their education is effective.
Postmarket Surveillance
We’ll keep an eye on the growth of your medical device…
As your teenage medical device moves into adulthood there are bound to be problems. Regulatory bodies require reporting on these issues. Our team is here to help document your sometimes wayward teenager (typical quality issues) and ensure you’re handling them properly.
Management Review
And check that all the work you’ve done to raise this medical device baby is on track with regulations and the quality management systems are working efficiently…
Internal Audit Management
And ensure that the correct audit management systems are in place BEFORE the FDA or a notified body has to get involved.
Scaling ON AND ON AND ON
Great job raising your medical device baby! From here, the world is their oyster. Release them into the market to keep growing and be proud of the work you put in. But always remember to continually check in on your medical device baby as it makes its way in the open market.
Want help keeping an eye on your medical device adult? The leanRAQA team knows exactly how to help at this point in the timeline too, and we can guide you through the best regulatory strategy for the future as well as ensure your adult medical device maintains all the necessary quality assurance checks and balances. Let our team of experts help!
Don’t find yourself in a “too little, too late” situation. Let the leanRAQA team keep you at the right place in the process within the right time frame.
Two Submission Pathways Diverge in a Wood…..Do You Know Which Path to Take?
Download my FREE Regulatory Pathway Assessment tool, which walks you through the specifics of choosing a regulatory submission pathway.
Then pick an open half hour on my calendar and we can chat about your regulatory submission needs.
