BRIDGING CONSULTING LLC is a boutique Regulatory, Quality and Clinical consulting firm dedicated to providing strategic and operational consulting services to AI startups and medical device companies. We strictly follow all timelines and focus relentlessly on quality and results. Our approach is to cultivate long-term partnerships with our clients.
Regulatory
Helping clients define regulatory strategies based on product characteristics, intended uses, target marketing claims and benefit/risk profiles, to achieve speed-to-market and competitive advantage.
Quality
Building a scalable and robust Quality Management System (QMS), compliant with FDA QSR & ISO 13485, as the foundation for making safe, effective and high-quality medical devices.
Clinical
Assisting clients with determining and negotiating pre- and post-market clinical study strategies with the FDA.
Here's what some of our clients are saying about
BRIDGING CONSULTING…
“We worked with another 510(k) consulting firm, until we received a 27-page AINN hold letter from the FDA. Bridging Consulting helped us understand why we received so many deficiency questions in the first place and within weeks helped create a clear deficiency response strategy …”
- Medical Device Company CEO
EXPERTs
Bridging Consulting LLC was founded by a medical device industry veteran with more than 20 years’ experience, including 150+ PMA, IDE, 510(k) and De Novo approvals. Its team of 15+ expert consultants with more than 320 years of combined experience offer high-quality consulting services 24/7/365.