Secure Software Development and Cybersecurity for Medical Devices

Medical device software development requires deep regulatory, technical, and cybersecurity expertise. You can trust Bold Type to develop usable, beautiful, and functional software that is secure and meets FDA’s requirements. 

Already have an engineering team? We can help you navigate the FDA’s latest cybersecurity requirements to avoid regulatory delays.

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We simplify and accelerate the complicated process of developing secure software for medical devices

90% of medical device and digital health companies fail… because they encounter unexpected delays in a years-long process, which eat up additional capital.

Focused Ultrasound Foundation

Companies underestimate the necessary balance across the three factors of development:

Regulatory

77% of development costs are devoted to FDA related activities. Focused Ultrasound Foundation

Usability

Poor usability can delay FDA clearance and limit market adoption.

Cybersecurity

Tremendous knowledge and skill are needed to develop software that meets FDA's cybersecurity requirements.

Developing secure software for medical devices is a process.
We drive that process with you.

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.

Partnering with Bold Type will ensure you:

Meet all FDA requirements for fast clearance and smooth audits

Bypass technical hurdles that cause months-long delays to your process

Avoid usability and security risks

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Why cloud connectivity
is a medical device
requirement

New technology makes it easier than ever to make medical devices wireless and cloud connected. In this video we cover the 3 areas that have enabled this advancement and how you can apply that to your medical device. Watch To Find Out

Which 3 questions should you ask before picking a developer?

Insist on these Answers

Our Services

Digital Health Apps

Secure Software for Medical Devices

Cybersecurity Consulting

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What People Say

If I develop a connected medical device, I'll have Bold Type build it. I've interviewed hundreds of medical device experts – yet Jose Bohorquez's team stands alone with cloud-connected devices. How heartily do I endorse Bold Type? I'll personally pay your invoice if you're not completely satisfied after a month How's THAT for an endorsement?!
Joe HageChair, Medical Devices Group (355,000+ members)
An emphatic Yes! to Bold Type, the most knowledgeable, effective, budget-conscious, expedient, connected medical device developer I know. In fact, Bold Type is so dedicated to product development excellence, I enlisted them to develop our entire platform. Bold Type gets my highest recommendation for connected, wireless medical device product development.
Marc BeerCo-Founder, Chairman & CEO, Renovia
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Our Co-Founders, Your Success Partners

Jose Bohorquez, PhD

President

20 years of experience in medical device product development. PhD in electrical engineering and computer science from MIT.

Mohamad Foustok

Chief Software Architect

30 years of experience in cybersecurity and secure software development (embedded, mobile apps, cloud computing, etc.)

Andres Echeverry

Chief Operating Officer

15 years of experience leading secure software development teams. Bachelor's in engineering, Master's degree in management from Harvard.

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