Team

Parth Kothari

Senior Principal Consultant

Parth is a results-driven leader with over 13 years of experience in the regulated healthcare industry, specializing in the development and commercialization of complex medical devices and combination products. He has successfully led programs from concept through launch at global pharmaceutical and medical device organizations.

Parth brings deep expertise in program management, product development, regulatory compliance, and continuous improvement. His hands-on experience spans a wide range of systems such as pen injectors, auto-injectors, wearable injectors, introducer sheaths, and drug-eluting balloon catheters.

Guided by a mission to deliver impactful healthcare solutions, Parth combines innovation, technical excellence, and strategic execution to bring safe, effective, and patient-centric products to market.

Academic & Professional Qualifications:
  • B.S.E. Biomedical Engineering, Case Western Reserve University
  • M.S. Applied Biomedical Engineering, Johns Hopkins University
Training, Quality Systems, & Specialties:
  • Program Management
  • Combination Product / Medical Device
  • Design Controls, Risk Management, Human Factors
  • New Product Development and Lifecycle Management
  • Customer Management
  • Product Remediation – Form 483, Warning Letter, DHF
  • Regulatory Compliance
    • ISO 13485
    • 21 CFR Part 820
    • ISO 14971
    • ISO 11608
    • IEC 62366