Accomplishments

  • Responsible for the commercialization of over 15 medical products


  • Responsible for over 35 FDA 510(k) clearances


  • Generated product clearances for distribution in 9 European Union (EU) member countries


  • Generated product clearances for distribution in 19 non EU foreign countries


  • Developed 30+ Standard Operation Procedures


  • Participated in six external FDA audits


  • Participated in 20+ external ISO audits


  • Managed over 10 face-to-face pre-IDE product meetings with the FDA


Bill has extensive experience in the medical device industry involving design, development, and regulatory and quality compliance of medical products for worldwide distribution.  ​His expertise includes detailed product development process execution, regulatory strategies and implementation compliance and quality design control process adherence.


As VP of Quality and Regulatory Assurance for InfoBionic, Inc., a digital health startup designing heart arrhythmia monitors with wireless connections to a cloud-based software platform, I managed all quality system requirements, generating FDA 510(k) applications and developing technical files for the CE Mark in Europe and other foreign country clearances. 

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 As Vice President of R&D and Regulatory, Quality and Clinical Affairs for AgaMatrix Inc., the designer, developer and manufacturer of innovative biosensors and blood glucose monitors for diabetes care Bill was responsible for the design and development of state of the art blood glucose meters for monitoring Type 1 and Type 2 diabetes and managed the worldwide clearance of the blood glucose meters and fully integrated mobile health manager applications (Apps). Responsibilities included managing the product management and clinical teams, generating FDA 510(k) applications and developing technical files for European and other foreign country clearances.


As Vice President of Research and Development, Regulatory and Quality for Eleme Medical, a venture-backed laser aesthetics company dedicated to providing market-leading technology in all areas of body contouring, Bill was responsible for engineering development, regulatory and quality compliance for aesthetic diode lasers for worldwide distribution. Responsibilities included managing the engineering design team, generating FDA 510(k) applications and developing technical files for European and other foreign clearances.


As Senior Vice President of Operations for Candela, a leading global aesthetic laser device company with a comprehensive product portfolio and global distribution ranging from body contouring, hair removal, wrinkle reduction, tattoo removal, through the treatment of superficial vascular and pigmented lesions, acne, leg veins and cellulite, Bill was responsible for the design, development, regulatory and quality compliance and manufacture of aesthetic laser systems for dermatology and plastic surgery.  Responsibilities included managing the engineering design and manufacturing teams, generating FDA 510(k) applications and developing technical files for European and other foreign clearances.


Bill holds a B.S. degree in Electrical Engineering from the University of Lowell and an M.B.A. degree from Boston University.

William H. McGrail, B.S., M.B.A.

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