Our Approach
Principal Consultant and Training Director
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Vern Geckler is president, owner and principal consultant for Procenius Consulting, a medical device consulting and training firm specializing in medical device new product development regulation. As an engineer and project manager, Vern has 19 years of hands-on, “in the trenches” new product development experience specializing in medical device design control and risk management.
Vern has led numerous development teams through the product development life cycle which has given him invaluable experience with the “nuts and bolts” and practical implementation of design control regulation. His experience includes but is not limited to developing electromechanical, disposable, implantable, software devices, and IVD (LDTs) medical devices.
Vern is the author of Design Controls, Risk Management and Process Validation for Medical Device Professionals. A complimentary copy of this handbook is provided to all consulting clients or training attendees.
Vern has significant experience in:
- Implementation of entire design control processes from the ground up
- Remediation of design control and risk management processes after FDA issued 483s, warning letters and consent decree
- Trained numerous medical device companies in design control and risk management regulation with practical implementation
- Medical device new product development design engineer, process validation engineer, project manager, and program manager
- Interpreting Design Control Regulation
- Developing Design Input Requirements
- Developing Design and Development Plans
- Developing Validation Master Plans
- Developing Verification and Validation Protocols/Reports
- Executing Design Changes
- Leading and Documenting Design Reviews
- Planning and Executing Design Transfer
- Developing Design Control SOP’s
- Mechanical Design of Medical Devices (3D CAD and Drawings)
- Development of process validation protocols and reports
- Risk management planning and execution
- Leading numerous cross-functional teams in the development of medical devices from concept phase to commercialization
Education and Certifications
Bachelor of Science (Mechanical Engineering); Brigham Young University
Masters of Mechanical Engineering (Design Emphasis); University of Utah
Masters of Business Administration; University of Michigan
Certified as a Project Management Professional (PMP); Project Management Institute