- Requirements generation and traceability
- Design and manufacturing capability
- Risk assessment and mitigation
- Design verification and validation
- Manufacturing process development and validation
- Packaging Design and Validation
Provided product development and operations expertise for multiple Class III PMA submissions. Led technical staff through all program phases, including requirements generation, design and process development, design verification and validation, process validation, design transfer and product launch.
Results: Successful clinical trial followed by approval and product launch.
Provided technical expertise and guidance to emerging medical device company. Focused resources to maintain schedule and compliance with 21 CFR 820 / ISO 13485. Made key decisions for design and process development to support optimal submission strategy.
Results: On-time product approval, enabling next round of funding.