- QMS Requirements – FDA 21 CFR Part 4, Design Control vs Change Control
- Device Assembly and Testing Considerations
- Platform technologies vs customizations vs bespoke designs
- Development of Device Packaging, Labelling, Instructions and Training Material
- Role of Human Factors Engineering
Developing, launching and supporting a drug-delivery autoinjector requires specific systems, procedures, capabilities and skills.
Mark Howansky, Vice-President, Device Development and Commercialization, Viridian Therapeutics