FDA Medical Device Regulatory Affairs Services
  • ​​​BRC medical device development teams are composed of technical, regulatory and medical experts with experience in facilitating the medical device development plans for timely submission of successful applications.
  • Early involvement of BRC regulatory device specialists with your medical device development team helps you leverage a broad experience base to better accelerate your medical device development program, and account for regulatory submission costs for investors.
  • BRC also partners exclusively with an international partner for clients seeking EU and UK registration for their devices.

EU and UK Consult Services for Med Devices

Click Contact Us to inquire directly about BRC's exclusive partnership for getting US approved devices registered in EU and UK.

BRC - a Regulatory Device Accelerator

BRC is a regulatory accelerator for:
  • Disease Monitoring Devices;
  • Medical Diagnostic Devices;
  • Mobile Health Apps.

The Right Path & The Right Plan

  • BRC medical device teams are comprised of experts in engineering, medical and regulatory sciences who have a broad range of in-depth expertise in helping to create and accelerate your development plan.
  • BRC teams do this by creating the right regulatory path, defining the right battery of technical validation, safety and clinical studies, and compiling and submitting robust medical device applications.

For Entrepreneurs

BRC's Expert Device Development Report (EDDR™)
  • BRC's EDDR™ provides a complete technical and regulatory plan of your device development program, with integrated timelines and associated costs, including optional Manufacturing estimates.

FDA Medical Device Services

Comprehensive Regulatory Affairs:
  • Regulatory pathfinding.
  • FDA meetings, feedback and other communications.
  • FDA meetings management.
  • Special postmarketing services click here 
Device Marketing Applications & Submissions:  
  • FDA-compliant compilation of support documentation, and writing and submitting applications.
     Examples of device application types include:
  • 510(k) (Premarket Notification).
  • PMA (Premarket Approval).
  • De Novo (Evaluation of Automatic Class III Designation).
  • HDE (Humanitarian Device Exemption).
  • PreSub and other Q-Sub type submissions.
  • Third-party reviews.
  • Requests for FDA feedback regarding FDA feedback on classification.
Quality System Review & Implementation:
  • QS Regulations (QSR) compliance assessments, QSR Plans, SOPs, etc.
Supportive Data Strategies: Design, implementation and analysis of:
  • Technological characteristics of new devices.
  • Device usability and related human factors.
  • Preclinical and clinical information for PMAs, including design, implementation and analysis. 
Device Postmarketing Services (click here)
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