Who We Are...
Procenius Consulting (Wasatch Consulting Resources LLC) is owned and operated by medical device professionals. We know the industry and we know what our clients need to be successful. We focus on helping medical device companies interpret and implement effective medical device design control and risk management systems. We also focus on helping medical device professionals develop basic and advanced design control and risk management knowledge through design control and medical device risk management training courses.
Principal Consultant and Training Director
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
Who We Serve...
- We specialize in serving medical device manufacturers and professionals
- We understand that the consulting and training needs for this industry is unique and have customized our techniques to optimize the learning experience to help medical device professionals effectively understand medical device regulation.
OUR BUSINESS OPERATIONS ARE BASED ON THESE VALUES
- INTEGRITY: We put the highest value on being fair and honest with our clients. Our employees will maintain the highest level of integrity and fairness while performing all of their assignments.
- HIGH QUALITY: We employ high-quality professionals and we only accept high-quality work to delight our clients.
- CUSTOMER DELIGHT: We are not satisfied until our clients are completely delighted with our services.