September 11, 2025

At Maven Regulatory Solutions, we know FDA rules can feel like a moving target—especially for medical device cybersecurity.

The FDA’s new guidance (June 2025) is no exception. It’s long, detailed, and it asks for real action to keep patients safe and companies compliant.

If you feel overwhelmed, you’re not alone. The good news? You don’t have to do this alone—Maven is here to guide you.

 

Why This Update Matters

Today’s medical devices are more than machines. They connect to:

  • Networks
  • Cloud platforms
  • Other hospital systems

This makes healthcare smarter—but also more open to hackers and malware.

The FDA knows this. That’s why the 2025 guidance pushes manufacturers to treat cybersecurity as an ongoing process, not just a one-time step.

 

What’s New in 2025?

Here’s what device makers need to focus on:

1.Software Bills of Materials (SBOMs)

  • A full list of every software part inside your device—commercial, open-source, or third-party.
  • Must be updated regularly.
  • Must link to any known risks or vulnerabilities.

2. Vulnerability Monitoring

  • No “set and forget.”
  • You need systems to spot new risks quickly, fix them fast, and update users.

3.Cybersecurity Labeling

    Labels must explain:

  • How the device connects
  • How long it gets security updates
  • Who users can contact if they find a problem

Malware Prevention

  • Devices must leave the factory clean and protected.
  • Companies must show controls against malware during production.
  • Full checks before devices ship.

 

What Does This Mean for You?

This update raises the bar. It means:

  • More detailed documentation
  • Longer testing and development timelines
  • Stronger supplier and supply chain checks

But this is not just paperwork. It’s about:

  • Patient safety
  • Avoiding recalls
  • Protecting your business from cyber risks

 

Maven’s Practical Approach

Here’s how Maven helps you meet these new rules:

  • Gap Analysis – We check your current process vs. FDA requirements, giving you a clear action plan.
  • QMS Updates – We help add cybersecurity into your quality system so it’s part of daily work.
  • Stronger Security Testing – We expand your test plans, add automation, and reduce surprises.
  • SBOM Setup – We guide you in building and maintaining SBOM tools and workflows.
  • Supplier Management – We help you set clear rules and expectations for suppliers.
  • Regulatory Submissions – We prepare FDA submissions that cover every point and clearly explain your cybersecurity plan.

 

Why Work with Maven?

Because you need more than a checklist.

You need a partner who:

  • Understands FDA rules
  • Knows medical devices
  • Can turn complex rules into simple, practical steps

We’ve supported device makers of all sizes, helping them stay compliant and confident.

 

Ready to Act?

The FDA’s cybersecurity rules are changing fast. Waiting can put your product at risk.

???? Reach out to Maven Regulatory Solutions today.
 Let’s turn these new requirements into an opportunity to lead—safely, securely, and compliantly.