Ontogen Medtech

Ontogen is a medical device development firm partnering with entrepreneurs, startups and large organizations worldwide to bring their innovations from concept to commercialization. We are focused on class I, II and III hard tech and in-vitro diagnostic devices in all areas of medicine. We are experts in product design and prototyping but are also the one-stop-shop team for hire to comprehensively and cohesively develop the design history file within a custom right-sized QMS. We handle it all for startups and entrepreneurs to ensure they are prepared for FDA submission and/or inspection and eventual commercialization.