How Sunrise Labs Leads Under the FDA’s New Cyber Rules

The landscape of medical device cybersecurity has officially changed. The transition from a framework based on “shoulds” to one defined by “musts” has raised the bar for regulatory compliance, security rigor, and patient safety.

The FDA’s updated guidance on cybersecurity in medical devices. At Sunrise Labs, we are proud to announce that our Secure Product Development Framework (SPDF) is already fully aligned with these new FDA expectations. More than just compliant, our SPDF is complete, thorough, and proven—built not just to meet the requirements of the past, but to anticipate and address the cybersecurity demands of the future.

Meeting “Musts” Before They Were Mandated

The FDA’s previous guidance emphasized what manufacturers should do: risk assessments, threat modeling, secure coding practices, and vulnerability management. At Sunrise, we treated these shoulds as musts from the beginning.

Our SPDF has long embedded:

• Secure-by-design principles
• Threat and vulnerability analysis at every development phase
• Robust authentication and access control strategies
• Patchability and postmarket support planning
• Transparent Software Bill of Materials (SBOM)

Now that the FDA’s guidance has evolved to codify these expectations, our framework remains ahead of the curve—not playing catch-up.

Already Aligned with New FDA Requirements

The FDA’s latest guidance, which includes clearer cybersecurity expectations for premarket submissions, defines what device manufacturers must demonstrate to ensure safety and effectiveness. This includes:

• Cybersecurity risk management as part of the design control process
• Inclusion of threat modeling and penetration testing results
• Complete documentation of cybersecurity controls
• Evidence that updates and patches can be deployed postmarket

Sunrise Labs’ SPDF already includes all of this—and more.

Our teams have developed and delivered FDA-cleared devices using this framework. We don’t just check boxes—we build security into the DNA of every device.

A Framework Built for Safety, Security, and Speed

Cybersecurity is too important to be an afterthought. At Sunrise, we integrate security from concept through commercialization:

• Cross-functional collaboration between systems, software, risk management, and QA
• Continuous alignment with FDA, NIST, AAMI, and UL guidance
• Design and development templates that accelerate compliance
• Comprehensive design history file (DHF) support for regulatory submissions

Our SPDF provides a structured, repeatable, and defensible approach—one that streamlines FDA submission readiness and reinforces patient trust.

Why This Matters for You

If you’re developing a connected medical device, the stakes have never been higher. Non-compliance can mean delays, rejections, or even market withdrawal.

Choosing Sunrise Labs means:

• Reduced regulatory risk
• Accelerated time-to-market
• Embedded cybersecurity expertise
• Confidence that your device is secure—by design, not by patch

Let’s Build Secure Medical Devices—Together

The new FDA guidance sets a higher bar. Sunrise Labs has already cleared it.

Let’s talk about how our SPDF can support your product from day one—so you can focus on innovation while we ensure compliance, security, and patient safety.

Contact us to learn more or schedule a discovery session with our cybersecurity team.