Medical Device Cybersecurity Consulting
BioVision helps manufacturers meet the cybersecurity requirements that the FDA and EU regulators now demand of connected and software driven medical devices. Cybersecurity is no longer optional documentation - under U.S. law, the FDA can refuse to accept a submission that lacks adequate cybersecurity information. We are experts in the latest regulatory requirements for medical device cybersecurity, with a strong record of supporting successful FDA and MDR approvals.
Why cybersecurity is now a gating requirement
A vulnerability in a connected medical device can directly endanger patients. In response, regulators have made cybersecurity a mandatory part of the approval process:
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In the United States, section 524B of the FD&C Act requires manufacturers of “cyber devices” to demonstrate a plan to monitor and address vulnerabilities, a secure development process, and a Software Bill of Materials (SBOM). Submissions without this can be rejected at intake.
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In the European Union, the MDR requires cybersecurity to be addressed as part of the General Safety and Performance Requirements, guided by MDCG 2019-16.
What a compliant cybersecurity submission includes
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Threat modeling and security risk assessment.
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A Software Bill of Materials (SBOM) identifying all software components.
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Secure product development lifecycle (SPDLC) evidence, aligned with IEC 81001-5-1.
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Vulnerability management and coordinated disclosure processes.
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A post-market cybersecurity plan for monitoring and patching.
How BioVision supports your device cybersecurity
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Gap assessment against FDA section 524B and EU MDR expectations.
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Threat modeling and cybersecurity risk management (aligned with AAMI TIR57 and ISO 14971)..
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SBOM creation and management.
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Premarket cybersecurity documentation for your FDA or MDR submission.
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Post-market vulnerability management and update planning.
Frequently Asked Questions
Does the FDA require cybersecurity documentation for my device?
If your device includes software and can connect to a network or another device (a “cyber device” under section 524B), the FDA requires cybersecurity information in your premarket submission and can refuse to accept submissions that lack it.
What is an SBOM and why do I need one?
A Software Bill of Materials is a complete inventory of the software components — including third-party and open-source code — in your device. Regulators require it so that vulnerabilities in any component can be tracked and addressed throughout the device's life.
Is cybersecurity a one-time submission task?
No. Regulators require ongoing post-market cybersecurity — monitoring for new vulnerabilities and issuing updates. BioVision helps you build a sustainable process, not just a one-time document.