Our services
We’ll help you achieve regulatory clearance for novel medical devices, set up the systems you need, and respond to the unexpected.
Dr. Adam Odeh, CEO and founder, has over 10 years of experience bringing novel technologies to market, in fields ranging from Artificial Intelligence to Direct-to-Consumer devices.
Regulatory Affairs
Submission strategy and planning
Submission writing
Product classification
FDA interaction and negotiation
Advertising and promotion compliance
Product Strategy
Quick-to- market opportunities
Product pathway definition
Product viability and roadblocks analysis
Competitor analysis
Quality Assurance
Quality System design and improvement
Audit planning and execution
ISO 13485/MDSAP Certification
Documentation backfill and technical file preparation
Emergencies
Warning/IHCTOA Letter response
Form 483 response and planning
Refuse-to-accept submission decisions
Support for surprise audits
Meet Dr. Adam Odeh, CEO and Founder
Dr. Adam Odeh is a seasoned medical device leader and startup veteran, with over a decade of experience bringing new technologies to market. Dr. Odeh is a former Director of Regulatory Affairs and Quality Assurance for medtech startups ranging from AI/ML software applications to in vitro diagnostics.
Notable leadership, strategy, and clearances at 23andMe and Overjet.
Working in the trenches with startup leaders, engineering teams, and VC investors, Dr. Odeh knows how to create regulatory strategy as products are being built, and how to gain regulatory clearance in the US and internationally for entirely novel technologies.
Dr. Odeh has a Ph.D. in Microbiology and Immunology from the University of North Texas, a Bachelor’s degree from Cornell University, and is a member of the Regulatory Affairs Professional Society.
News
Stanford Talk: Regulation meets innovation
Check out my recent talk at the Stanford Graduate School of Business.
Watch the full recording here.
