What Information FDA is Expecting for Cyber Devices?
In an era where medical devices are increasingly interconnected and software-dependent, cybersecurity has become a critical component of healthcare. The FDA recognizes the importance of
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.
Tremendous knowledge and skill are needed to develop software that meets FDA’s cybersecurity requirements.
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.
Poor usability can delay FDA clearance and limit market adoption.
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.
Tremendous knowledge and skill are needed to develop software that meets FDA’s cybersecurity requirements.
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 In 2024, however, the bar was raised dramatically with the release of the draft guidance: Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act.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.
To address this inefficiency, we created a robust Foundation App that includes all the essential features most medical device apps require:
Reliable Bluetooth Low Energy connections for seamless device integration.
Ensuring only authorized users can access the app.
Smooth user onboarding processes for a better user experience
Securely sending data to the cloud for storage and analysis
Update your device’s embedded software and implement security patches directly from the cloud.
Single code base capable of deployment as an iOS, Android, Windows, MacOS, or Linux application.
commonly found in medical device apps include the following.
Clear and insightful data presentation for easy interpretation.
Allowing users to log symptoms for better health monitoring.
Timely notifications and reminders to enhance user compliance.
Efficiently delivering relevant content to users.
Patients will use your device more often if it’s fun to use, so let’s turn therapy time into game time.
Clear and insightful data presentation for easy interpretation.
Why burden patients with tracking device use when your app can do it automatically?
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