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
