YOUR PATH TO SUCCESS
Regulatory
One of the biggest risks with any medical device is the regulatory path. Our collaborative regulatory and product development services reduce risks, enabling you to develop products that are designed, documented, and tested to achieve FDA approval.
Regulatory Approach
We anticipate questions the FDA may have, foresee where problems may arise and address issues that might come up. The collaboration between engineering and regulatory is a unique service that results in a quality regulatory submission, increasing the chances of a successful approval.
YOUR REGULATORY GOALS
Unsure of your clinical indications? Weighing de novo vs. 510(k)? We’ll help you start with the basics: understanding what can be done, the timelines, and the risks associated with different approaches.
- Regulatory Assessment
- Regulatory Roadmaps
- US FDA Strategy
- Regulatory Gap Analysis
- EU and Canadian Strategy
- FDA 510(k) submissions
- FDA de novo submissions
- Technical File Review
- Medical Device Classifications
- Management of warning letters, regulatory actions, and product recalls
A Vested Stake
Regulatory consultants can give advice and put up roadblocks, but at Blur we live and work within our recommendations. We actually execute the product development, write the documentation, and perform the testing that augments the regulatory strategy.
Eliminate Obstacles
There are always obstacles to overcome. With our regulatory strategy in mind as we plan and develop, we can avoid major risks from the onset. It’s more than just getting a working device; it’s about getting a device that has the regulatory compliance it needs for the market.
Engineering Collaboration
Collaboration between regulatory and engineering enhances the speed, the output, and the quality of the submission. Our regulatory group is on-site and has worked hand in hand with our engineering team for years.
HOW IT WORKS
Our Regulatory Approach
01
Assess
First, we understand your product goals. What do you want to claim and when? Will we need clinical trials? What will the device classification be? And what does the regulatory landscape look like in your category?
Tie it all together
Here's What's Next
03
Submit
Regulatory, engineering, quality, and testing. The entire team comes together to deliver the data needed for a quality, successful submission. And if the FDA has additional questions, we are right here to answer them.
WHAT WE'VE DONE
Our Work
We're here to help you create
Quick Assessment
Sometimes you need to get the ball rolling. We can help you position your regulatory thinking with a quick 30 minute talk. We can prepare you for what to expect, what hurdles you may encounter, and the commitment you’ll get from us.