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The Industry Experts in Secure Medical Device Software

Software Development:

Building secure apps and embedded software optimized for cloud-connected medical devices.

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Cybersecurity Consulting:

Expert guidance and support to secure your device. Independent fuzz and penetration testing for cloud, web, app, and embedded systems. FDA documentation prep.

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Our proprietary App Foundation

Customized to meet your needs

Our proprietary App Foundation

Customized to meet your needs

Companies underestimate the necessary balance across the three factors of development

Regulatory

You must follow dozens of standards and FDA guidance documents to build compliant software.

REGULATORY

Patients deserve safe and efficacious medical devices. That’s why the FDA takes their mission very seriously and demands a lot from medical device manufacturers. If your medical device incorporates an app, you are responsible for developing, testing, and documenting your app in compliance with dozens of FDA regulations and recognized standards. You need a partner who knows these regulations inside out and has a quality management system in place that is compliant and practical.

Usability

Poor usability can delay FDA clearance and limit market adoption.

USABILITY

Advances in consumer product usability have created a high bar for medical device companies. Patients and healthcare providers want products that are intuitive, easy to use, and even delightful. And FDA demands that you take usability into account, test for it, and document your studies. The last thing you want is to fail a summative usability study late in the game because your app development partner does not know the best practices in usability. Trust Bold Type to deliver apps with proven features that meet regulatory requirements and delight users.

Cybersecurity

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

CYBERSECURITY

The FDA has cared about cybersecurity for a long time. In 2024, however, the bar was raised dramatically with the release of the draft guidance: Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act. If your medical device is a “cyber device” (and there is a 99% chance it is if it incorporates an app), your documentation must include architecture security views, threat modeling, threat analysis, management plans, testing results (penetration, fuzz, etc.), a software bill of materials (SBOM), monitoring and incident reporting, and more. With Bold Type, this all comes standard.

Who We Are

Bold Type is a leading provider of secure software for medical device startups and OEMs.

Our expertise spans app development, embedded software, cybersecurity, and regulatory compliance, helping clients bring medical devices to market quickly and efficiently.

Who It’s For

“I don’t have an in-house software development team.”

Bold Type can develop your software.

“I have an awesome software team, but we have gaps in our medical device expertise.”

“I have an awesome software team, but we have gaps in our medical device expertise.”

Bold Type can provide consulting expertise to fill those gaps.

“I have an awesome software team with medical device expertise, but gaps in cybersecurity.”

“I have an awesome software team with medical device expertise, but gaps in cybersecurity.”

Bold Type can provide cybersecurity consulting and prepare your FDA cybersecurity documents.

“My team can do it all: medical device apps, firmware, cybersecurity, etc.”

Bold Type can provide a second set of eyes and perform the independent cybersecurity testing FDA requires.

Why Choose Us

ISO 13485 certified with deep expertise in both software development and cybersecurity, we leverage proprietary tools and ready-built frameworks to save time and cost, while ensuring compliance.

Our clients avoid costly delays and gain a trusted partner who understands the unique challenges of medical device software.

Success

Success

Client Success

From wearable devices to in-clinic diagnostics, Bold Type has helped companies at every stage of development—delivering results in women’s health, cardiac care, fall monitoring, and more.

"Bold Type has been a trusted product development partner since our earliest days. They not only led the development of the Leva® Pelvic Health System, including fundamental engineering, prototyping and software design, they have also worked seamlessly with our internal team to continuously improve our app for greater patient engagement and satisfaction."

"For sophisticated systems that include embedded software, mobile applications, and cloud, Bold Type's expertise in cybersecurity is truly unparalleled in the industry. They've been a trusted partner for years and I couldn't recommend them more highly."

Bold Type has been a trusted partner of our product development team for several years. We have valued their technical expertise, ability to help us troubleshoot issues and solve problems. Their QMS system and attention to detail in building out DHFs has been robust. They have also helped us learn quickly with early-stage exploration and assessment.

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When it comes to medical device software and cybersecurity, you don't have to go it alone. We're here to help!

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