
You don’t need a full QMS: Leverage your development partner and contract manufacturer
In today’s competitive and fast-paced market, efficiency and lean operations are essential. For startups and small businesses, setting up
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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