Medical Device FDA Regulatory Consulting Services We Offer

•    Regulatory landscape assessment
•    Evaluate and provide guidance on all aspects of regulatory strategy for product development
•    Early support for medical device development, biologic development, IVDs, and combination products
•    Gap analysis
•    Pre-clinical / clinical test plan and anticipated timeline
•    Letter-to-file consult and review
•    Provide clients with an ‘FDA perspective’ review of submissions and strategies
•    Due diligence services
•    Short and long term FDA strategy, including submission and meeting strategy

Our Integrated Approach

MCRA is the world leading regulatory advisor to the neuro-musculoskeletal industry on U.S. FDA related activities. Whether assisting on specific subjects or executing on complex pipeline strategies, MCRA’s regulatory team is a value-add to any potential client.

As a small boutique medical device FDA advisory firm, MCRA works closely with clients in developing ideas and providing reliable judgment. MCRA’s integrative multi-disciplinary approach in offering clinical, regulatory and reimbursement services allows MCRA to consider important factors that impact the cost, timing, and success of getting a product effectively approved and paid for.

Regulatory Advisory Services for FDA submissions on medical devices by MCRA


Contact a Regulatory Affairs Expert

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Glenn Stiegman

Glenn Stiegman

Senior Vice President, Clinical & Regulatory Affairs