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Professional Consultants

Carl H. Jacobs, Ph.D.
Operations, Quality Control Systems and Regulatory Interface

Dr. Jacobs has over 35 years of experience in the Medical Device Industry, most recently as VP Operations for the Collagen Products Division of Datascope and Managing Director of Bioplex Medical, BV. Prior positions include the Director of Quality Assurance for the Osteonics Division of the Stryker Corporation, VP Operations for Orthomet, Director of Research Laboratories at Zimmer and Group Leader at Howmedica, and Assistant Professor, School of Mechanical Engineering, Georgia Institute of Technology.

Dr. Jacobs currently consults to a number of startup medical device companies on topics ranging from R&D, Quality Assurance, ISO/CE registration, Operations and Logistics. His range of expertise from fundamental biomaterial research to full scale manufacturing provides companies with a significant competitive advantage within the device and diagnostic space. Dr. Jacobs attended the University of Vermont where he received his Bachelor of Science in Mechanical Engineering, his Masters and Doctoral Degrees and he holds several patents for novel medical devices.

Dr. Jacobs partners with client companies in the areas of:

  • Operational Readiness; focusing on the interface between R&D, production and cGMP/ISO Compliance

  • Quality Assurance; what systems are needed and how they can be implemented functionally and efficiently

  • ISO/CE registration; assessing operational readiness and the appropriate ISO Registrations and CE mark requirements

  • Operations: What a fully compliant and functional production operation looks for both sterile and non-sterile production.

  • Logistics; Evaluating vendors and material movement into, through and out of production to end users

  • R&D; Developing Research and Development standard practices and procedures, evaluating R&D plans and the transfer of product designs from R&D into Production.
      
Consultants
»Russell Donda
»David Greenspan, Ph.D.
»Mike Helmus, Ph.D.
»Carl H. Jacobs, Ph.D.
»James F. Kirk, Ph.D., MBA
»Monika Oli, Ph.D., MSE, PMP
»Thomas W. Sander, MS
»Chris Seid, Ph.D.
»Mark Tanner
»Donna Wheeler, Ph.D.
»Martin (Marty) Wynkoop