We elevate your team’s development capabilities to ensure the best possible product and seamless FDA clearance faster than doing it on your own.
90% of medical device and digital health companies fail… because they encounter unexpected delays in a years-long process, which eat up additional capital.
77% of development costs are devoted to FDA related activities. Focused Ultrasound Foundation
Poor usability can delay FDA clearance and limit market adoption.
New technologies are disrupting previous versions at a blistering pace.
FDA regulations and oversight are strict. The ability to quickly develop a product with the necessary documentation and testing is critical to a successful launch.
In today’s competitive and fast-paced market, efficiency and lean operations are essential. For startups and small businesses, setting up
Implementing a Quality Management System (QMS) for a medical device startup is not just an exercise in regulatory compliance;
3D printing has been a key technology for product prototyping for well over a decade. In the last few
President
Jose, with more than a decade's experience as executive and technical contributor, founded Bold Type to help medical device companies flourish
Chief Software Architect
Mohamad, a 25-year software architect and engineering leader, has profound expertise in embedded software, mobile apps, cloud computing, and cybersecurity.
VP, Product Development
Andres, a 15-year veteran spanning the full cycle of product development from product strategy to R&D to product launch, leads your strategic initiatives.
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