David Johnson is a medical device and industrial non-destructive testing compliance expert. Trained in X-ray scattering and materials research, David has held a number of technical, quality, and compliance roles. His 18-year career at GE included process engineering, advanced manufacturing, engineering, supply chain development, and product compliance. His initiation into Quality and Regulatory began as a contributor to the IEC 60336 X-ray tube imaging standard and from there expanded to CAPA, complaint handling, risk management, and recalls.
After his post-market experience, he gained pre-market experience in safety standard certification and risk management as well as regulatory compliance projects spanning IEC 60601 3rd Edition standards, the Medical Device Directive (MDD), Machinery Directive, Risk Management (ISO 14971), e-IFU regulation, and substance regulations. All of these programs were executed in global, multi-site businesses manufacturing complex imaging and patient support equipment.
Most recently, David served as Vice President of Quality and Regulatory at Transonic Systems, a medical device company in Ithaca, NY. There he oversaw the transition to ISO 13485:2016, overhaul of the complaint-handling process, revitalization of a continuous improvement program, and establishment of enhanced supplier controls.
David holds a Bachelor of Science in Physics from Guilford College and a Master of Science and PhD in Physics from Old Dominion University. He also completed post-doctoral studies at Brookhaven National Laboratory.
- ISO 13485, ISO 14971
- Medical Device Directive (MDD)
- Quality Management Systems
- Regulatory Compliance
- Medical Device Risk Management
- Project Management
- Product Design & Development
- Product Maintenance and Change Management
- Safety Certification and Testing
- Post-Market Surveillance
- Supplier Quality and Development
- Non-Destructive Testing
- Medical Devices including Class II, Class III, Sterilized, and Reusable