Christie Johnson
Partner, Prodct
I am a successful mechanical engineer and quality leader and have advised dozens of medical device, in-vitro diagnostic, and biotech (cell & gene therapy) startups to successful product launches. I have been a global mentor and pod leader for MassChallenge for the last year and would love to find more mentoring opportunities in the midwest.
Questions:
1. When do we need to implement a quality management system?
2. How do I select suppliers and partners for development?
3. Am I ready for clinical trials or FDA submission?