Medical Device Development
Utilizing our depth of experience and robust network of industry connections, the Genesis team guides innovators through the rigorous process of getting a medical device developed and successfully into the hands of clinicians. Our customers trust us for our ingenuity and collaborative efforts, and our achievements are reflected in hundreds of patents, 510k clearances, novel innovations and commercial exits. Many of our partnerships are still active across the orthopedic industry today.
Innovators who conceptualize a new solution to address an overlooked or unmet clinical need require expertise to navigate the regulated world of medical device clearance and market commercialization. Our team guides the process of developing their concept into a successful product solution.
Great ideas need strong financial management to ensure success. We bring governance advisors, legal, planning and reporting capabilities to the table for the start-up medical device companies we work with.
We partner with medical device contract manufacturing professionals to quickly turn ideas into prototypes and prototypes into production models. We then scale up validated solutions to full production inventory.
With experience in regulatory approval for Class I, II and III devices through an ISO 13485-certified quality system, our team can smoothly execute successful regulatory strategies including 510K, De Novo and PMA clearances.
With decades of medical device commercialization experience, we have a network of Independent Distributors who are poised and ready to tap into a variety of opportunities on behalf of our clients.
Contact
Reach out to our team if you have a great idea that you think can serve the medical community.