Bridging Consulting LLC

FDA regulatory, quality, and clinical consulting for medical device companies

11-50 employees

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About Bridging Consulting LLC

Bridging Consulting LLC is a boutique regulatory, quality, and clinical consulting firm specializing in FDA submissions and compliance for medical device companies and AI/ML startups. The firm's founder brings over 20 years of industry experience, with the team collectively managing 150+ PMA, IDE, 510(k), and De Novo approvals across 320+ combined years of expertise.

The firm focuses on three core service areas: regulatory strategy and FDA submissions, Quality Management System development compliant with ISO 13485 and FDA QSR, and clinical study design and negotiation. Their portfolio spans advanced medical technologies including AI-powered diagnostic software, implantable devices, surgical robotics, digital therapeutics, and remote patient monitoring systems.

Bridging Consulting positions itself as a U.S. agent for international medical device manufacturers seeking FDA market access. The firm emphasizes timeline adherence and long-term client partnerships, with particular expertise in navigating complex AI/ML regulatory pathways and responding to FDA deficiency letters.

Best For

Medical device manufacturers and AI/ML health technology startups seeking FDA regulatory approval, particularly those developing software as a medical device (SaMD), digital health products, or Class II/III devices requiring 510(k), De Novo, or PMA submissions. Especially suited for international companies needing a U.S. regulatory agent and companies facing FDA deficiency letters or inspection challenges.

Key Strengths

Extensive track record with 150+ FDA approvals across multiple submission types including complex AI/ML devices
Deep expertise in emerging regulatory areas including machine learning algorithms, digital therapeutics, and continuous glucose monitors
Team of 15+ consultants with 320+ combined years of medical device regulatory experience
Serves as U.S. agent for international manufacturers, bridging geographic and regulatory knowledge gaps
Proven experience responding to FDA deficiency letters and navigating complex regulatory challenges
Comprehensive service offering covering regulatory, quality, and clinical domains under one firm

Why Choose Bridging Consulting LLC

Choose Bridging Consulting when navigating FDA regulatory pathways for medical devices, particularly AI/ML-enabled products requiring specialized regulatory expertise. The firm's extensive approval track record and deep knowledge of emerging technologies like machine learning diagnostics, digital therapeutics, and connected medical devices makes them suitable for innovative health tech companies.

International medical device manufacturers will find value in their U.S. agent services and ability to bridge regulatory requirement gaps between overseas commercial devices and U.S. market entry. Expect a partnership-oriented approach with emphasis on timeline adherence and quality outcomes.

Healthcare Focus

Bridging Consulting operates exclusively in the medical device and digital health sectors, with specific expertise in FDA regulatory compliance, ISO 13485 quality management, and clinical trial design. The firm demonstrates deep vertical knowledge across multiple medical device categories including AI-powered diagnostics, surgical robotics, implantable cardiac devices, diabetes management systems, neuromodulation devices, and oncology companion diagnostics. Their work spans the complete product lifecycle from regulatory pathway determination through post-market surveillance and field corrective actions.

Ideal Client Profile

Medical device startups and established manufacturers developing Class II or Class III devices, AI/ML diagnostic software, digital therapeutics, implantable devices, or remote monitoring systems. Companies facing FDA regulatory challenges, deficiency letters, or needing strategic guidance on complex submission pathways. International manufacturers requiring U.S. regulatory representation and FDA communication support.

Specializations

AI/ML medical device regulatory strategy FDA 510(k), De Novo, and PMA submissions Quality Management System (QMS) setup and compliance Clinical study design and IDE applications EU MDR compliance Cybersecurity and human factors engineering Digital health regulatory pathways