Team

Max Lerman, PhD

Senior Principal Consultant

With over three years at the FDA as a member of the infusion devices team, Max has deep experience in developing and setting review practices for infusion, life-critical drug delivery, and electroporation systems and was also a member of AAMI ID and IP infusion pump committees. Prior to the FDA, Max spent over two years at Medtronic developing and maintaining electrocautery platforms. This industry experience and insider knowledge can be critical support to Suttons Creek clients and their combination product development and regulatory approval success. 

Academic & Professional Qualifications:

  • Bachelors of Science in Biomedical Engineering, Boston University College of Engineering

  • Masters of Science and Doctor of Philosophy in Materials Science and Engineering, University of Maryland College Park

  • Author of 11 peer-reviewed publications, 17 conference presentations, and 3 patent submissions  (to date)

Training, Quality Systems, & Specialties:
  • GMP Requirements & Industry Practices
  • UK Responsible Person FDA Quality Systems Regulations
  • Design Controls
  • Process Validation, Design Validation, Design Transfer
  • Stage-Gate Product Development Process
  • Combination Product Regulations
  • Combination Product Design & Development
  • Medical Device Design & Development
  • Global & Multi-site Program Management
  • Design For Manufacturing & Assembly
  • Disposables & Systems Development
  • Low & High Volume Disposable Devices
  • PMA & 510(k)
  • Computer-Aided Design
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