boldtype – 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.

Beautiful, Secure, Compliant Medical Device Apps

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.

Companies underestimate the necessary balance across the three factors of development

Regulatory

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

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 In 2024, however, the bar was raised dramatically with the release of the draft guidance: Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act.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.