Team

John Ziobro

Consultant

John Ziobro is an adaptable, results-oriented executive with over thirty years of experience in the medical device industry.  Creative and entrepreneurial in nature, John offers exceptionally strong, hands-on Executive and Management level expertise in Engineering and New Product Development, Quality and Regulatory Affairs, Sales and Marketing, and Manufacturing.  Experienced with start-ups, turn-arounds, market leaders and underdogs.  Skilled in developing and building long-term trusted business relationships.  Successfully launched over 85 medical devices.  Excellent in creating systems and infrastructures.  Over twenty-five years of international experience on six continents.  Earned a reputation for getting the job done right the first time.  Thrives in fast-paced and challenging environments.

Academic & Professional Qualifications:
  • Bachelor of Science – Mechanical Engineering, University of Wisconsin-Madison
  • Post-graduate courses in Anatomy, Bio-Medical Engineering, Business and Physiology. University of Washington-Seattle, 1985.
Training / Quality Systems / Specialties
  • FDA cGMP/QSR and ISO 9001/13485 quality management systems
  • FDA 510(k) and -marked MDD class I, II and III product registrations
  • CMDCAS, PAL, TGA, KFDA, SFDA, etc., regulatory compliance
  • ISO 14971 risk management; assurance cases; IEC 62366 usability engineering/human factors
  • UL, CSA and BSI electromechanical device compliance