President & CEO, Coombs Medical Device Consulting, Inc.
Craig Coombs has been the President of Coombs Medical Device Consulting (CMDC) since 2000. His company specializes in hands-on, innovative US, European and Asian regulatory strategies for start-ups and companies that need to change their strategies. CMDC is highly experienced in organizing effective FDA/NB meetings and all types of regulatory submissions (510(k), PMA, deNovo, Design Dossier, Medical Device License, etc.). CMDC skills include cost-effective First-In-Human (& VC milestone) clinical trial design, management and analysis. During his 26 years of medical device regulatory work, he has been instrumental for the early regulatory success of dozens of start-ups, and has been a Vice President of Medtronic in the areas of Regulatory Affairs, Quality Assurance and Clinical Studies. Mr. Coombs received his BS (Biology) from Stanford University. Mr. Coombs is adjunct faculty for the University of California (Santa Cruz) in Medical Device Submissions.