MBCA provides comprehensive regulatory and clinical consulting services for small companies and startups attempting to get their medical device through the regulatory process.
We have the real-world experience and expertise to determine what class your device ﬁts into, what type of regulatory submissions are required, what predicate devices are most appropriate, what clinical data is needed to get you to market, and how much time and money it will cost you before you can start making a proﬁt.
No matter what phase you’re in, MBCA can provide direction and hands-on support to help you. Below are a sampling of the services we offer:
Develop a regulatory road map
A clear path through the regulatory maze. We provide documentation and testing requirements as well as risk assessments. Our experience with the full range of device risks (low to high) facilitates being able to anticipate what the FDA will be looking for.
Identify Design Control deliverables
We will ensure that any Design Control deliverables required by the FDA are completed before you ﬁle your submission.
Write and deliver your submission to the FDA
We do all the technical writing and thoroughly review the completed submission to make sure everything is in order before sending it to the FDA.
Secure FDA market clearance/approval for your device
We will defend your submission during the review process with the FDA and assist with securing market clearance or approval for your device.