About

Trusted Expertise in Medical Device Regulatory Affairs

At BraunSolutions Regulatory Group, we are dedicated to empowering medical device companies to achieve seamless FDA compliance. Our mission is to navigate complex regulatory landscapes with clarity and precision, ensuring our clients’ innovations reach the market safely and efficiently. We uphold integrity, collaboration, and excellence as the cornerstones guiding every partnership and project.

Mock FDA Audits to Ensure Compliance

Discover crucial data showcasing our expertise and track record in regulatory success.

Years of Regulatory Experience

Over three decades guiding medical device firms through complex FDA regulations.

Successful Submissions

Count of product approvals facilitated by our expert consulting services.

Mock Audits Conducted

Number of simulated FDA inspections prepared to ensure client readiness.

Client Satisfaction Rate

Percentage of clients achieving compliance and approval with our guidance.

Decades of Expertise, Delivered with Integrity

Showcasing our FDA compliance credentials and proven success in medical device regulatory consulting.

FDA Compliance Certified

Certified for rigorous adherence to FDA regulations, ensuring your product meets all necessary standards.

30+ Years of Regulatory Experience

Over three decades guiding medical device companies through complex submission processes with proven results.

Trusted Mock FDA Audits

Providing realistic, comprehensive FDA audit simulations to prepare your team for successful inspections.