Mittal Consulting is a premium boutique regulatory and reimbursement consulting firm supporting innovative medical device startups and growth-stage manufacturers.

We help MedTech companies develop clear, practical strategies across FDA regulatory pathways, planning, market access, reimbursement, and commercialization. Our team works as an extension of our clients, helping reduce risk, accelerate development, and bring complex medical technologies to market with confidence.
Our regulatory services include:

• FDA regulatory strategy
• Pre-Submissions (Q-Submissions)
• 510(k) submissions
• De Novo requests
• Premarket Approval applications
• Investigational Device Exemptions
• Breakthrough Device and STeP designation requests
• FDA meeting preparation and representation
• Regulatory VC due diligence and gap assessments

Our reimbursement and market access services include:

• Reimbursement strategy
• Coding and coverage assessments
• DME and HCPCS pathway support
• Evidence planning
• Payer and commercialization strategy

We support medical devices across:

• Cardiovascular and structural heart
• Neurotechnology and neuromodulation
• Orthopedics
• Surgical, Ophthalmology and robotic devices
• Digital health, AI, and SaMD
• Wearables and remote monitoring
• Diagnostics and IVD
• Women’s health
• Rehabilitation and home-use devices

Mittal Consulting

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Mittal Consulting

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