Theresa Fisher
Senior Quality Engineer, ApiJect Systems Corp.
Expertise in medical device development, manufacturing, and post-market compliance. Particular experience in product realization, design controls, human factors, and regulatory and compliance.
My interest in mentoring stems from having worked with and for startups throughout my career and particularly an interest in helping bridge the gap from prototype/proof of concept medical devices to successful regulatory clearance.
Questions:
- How do I move from a prototype device to manufacturing and commercial ready?
- What elements do I need to prepare for a successful regulatory submission?
- What systems and procedures do I need to have in place for compliance purposes?