Regulatory and Clinical Consulting Services

Regulatory AffairsMBCA provides comprehensive regulatory and clinical consulting services for small companies and startups attempting to get their medical device through the regulatory process.

MBCA has 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:

Develop a regulatory road map

A clear path through the regulatory maze.  MBCA provides documentation and testing requirements as well as risk assessments. MBCA’s 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

MBCA will assist with ensuring that any Design Control deliverables required by the FDA are completed before you file your submission.

Write and deliver your submission to the FDA

MBCA does the technical writing and thoroughly reviews the completed submission to make sure everything is in order before sending it to the FDA.

Secure FDA market clearance/approval for your device

MBCA will defend your submission during the review process with the FDA and assist with securing market clearance or approval for your device.

Get quick answers to your questions about the regulatory maze »

Additional Regulatory and Clinical Consulting Services:

MBCA provides a full range of regulatory affairs consulting services to support your product development pipeline and emerging technologies, including:

  • Strategic regulatory planning
  • Bio-informatics and statistical analysis
  • Regulatory Assessments
  • Facility Registrations
  • Product Listings
  • Clinical Trial management