Regulatory Affairs Consulting

MBC & Associates provides comprehensive assistance to 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 submission is required for your class of device, and how much time and money it will cost you before you can start making a profit.

No matter what phase you're in, we can provide direction and hands-on support to help you:
  • Develop a regulatory road map. A clear path through the regulatory hurdles that will face your business including documentation and testing requirements and risk and obstacle assessments. Our experience with low and high risk devices has given us the ability to anticipate exactly what the FDA will be looking for.
  • Identify Design Control deliverables. We will assist with ensuring that all Design Control deliverables required by the FDA are completed before you file with the FDA.
  • Write and deliver your submission to the FDA.
  • Secure FDA approval for the first time. We will defend your submission during the review process with the FDA and assist with securing approval for your device or IVD.
  • Audit and manage critical contract suppliers.
  • Establish your first Quality System. We create procedures, provide training, support and stabilization.

Regulatory Affairs Services

We provide full-service regulatory affairs assistance to support your product development pipeline and emerging technologies including:
  • Strategic planning
  • Clinical study protocols & IRB approvals
  • Bio-Informatics and statistical analysis
  • 510(k) and PMA submissions
  • Project Management
  • Regulatory Assessments
  • Regulatory strategies & submissions
  • Design Control Process assistance

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