Mittal Consulting

Mittal Consulting provides regulatory consulting services for medical device manufacturers seeking FDA and EU-MDR approval. Led by CEO Kristen Mittal (RAC, PMP), the firm specializes in regulatory submissions across all device classes, from 510(k) clearances to Class III PMA applications. The company serves both early-stage startups and established manufacturers globally.

The firm's service portfolio includes regulatory strategy development, submission preparation, post-market support, and venture capital due diligence. Mittal Consulting employs ex-FDA consultants and maintains partnerships with universities including UCSF, OHSU, and Arizona State University. The team offers three engagement models: ad-hoc consultation, project-based work, and monthly retainer arrangements.

Client testimonials highlight the firm's work on cardiac monitoring devices, AI/ML medical devices, and orthobiologic solutions. The company also provides educational services through workshops, seminars, and guest lectures for academic institutions and medical device companies.

Mittal Consulting suits medical device companies that value personalized attention from ex-FDA reviewers and need regulatory strategy integrated with reimbursement planning. The firm's willingness to review extensive regulatory history before engagement demonstrates thorough preparation.

Companies should expect detailed regulatory pathway assessments, access to specialized consultants for specific device areas, and options for ongoing support through retainer arrangements. The firm's academic partnerships suggest commitment to current regulatory knowledge and industry best practices.

Mittal Consulting exclusively serves the medical device sector within healthcare. The firm's regulatory expertise spans cardiac monitoring, orthopedics, neurosurgery, AI/ML diagnostics, and 3D cell culturing platforms. Team members include ex-FDA reviewers from gastroenterology and OB/GYN divisions, providing specialized knowledge for device submissions in those therapeutic areas.

The company addresses the complete regulatory lifecycle from pre-submission strategy through post-market surveillance, with particular emphasis on helping early-stage medical device startups navigate complex FDA and EU regulatory requirements while preparing for commercialization and reimbursement challenges.

Medical device startups and manufacturers developing Class II or Class III devices requiring FDA 510(k), PMA, or EU-MDR submissions. Companies with novel technologies such as AI/ML applications, those seeking VC funding and needing investor-ready regulatory strategy reports, and organizations requiring integrated regulatory and reimbursement planning for commercial success.