Team

David Plescia

Consultant

With over 18 years in the Medical Device, Pharmaceutical and Life Sciences industries, David Plescia has a broad and deep knowledge of the FDA regulated industry. His experience spans from mechanical, electrical, and software development to quality control and regulatory workflows. He has provided a broad range of services to clients ranging from start-ups to Fortune 500 companies. One of David’s unique skill sets includes statistical and probabilistic methods specific to the Medical Device industry that meet or exceed the expectations of the CFR.

Academic & Professional Qualifications:
  • B.S. Mechanical Engineering, University of Dayton
  • M.S. Mechanical Engineering, University of Dayton
Training, Quality Systems, & Specialties:
  • Medical Device Directive (MDD)
  • ISO 13485
  • ISO 11608
  • ISO 60601-1
  • 21 CFR, Subchapter H (Medical Devices)