Cybersecurity services for medical devices
Empowering medical device manufacturers to build cyber-resilient solutions, from concept through post-market surveillance.
Therapeutic areas we support
Security expertise built for regulated devices
Five focus areas that cover the full lifecycle of medical device cybersecurity: from first threat model to post-market monitoring, backed by the leadership judgment to make the hard calls.
Regulatory Compliance Consulting
Guidance through complex global cybersecurity regulations: FDA, EU MDR, NMPA, PMDA, and beyond, so your submissions clear the bar the first time.
Learn more →Security by Design Services
Cybersecurity embedded into every stage of the medical device lifecycle: threat modeling, architecture, and secure development, from first design decision through deployment.
Learn more →Penetration Testing & Exploitability Validation
An ongoing, annually-renewed subscription that continuously proves which findings are actually exploitable in your device's real operating context, not a one-time scan that goes stale.
Learn more →Post-Market Services
End-to-end SBOM monitoring, triage, risk assessment, security testing, and coordinated vulnerability disclosure, managed on your behalf against your cybersecurity management plan.
Learn more →Executive Advisory & Fractional Leadership
A fractional Head of Product Security for teams that need senior leadership judgment now, without full-time overhead.
Learn more →Security that speaks regulatory fluently
We've sat on both sides of the table: building security programs inside medical device companies and reviewing submissions against FDA, EU MDR, and IMDRF expectations. That means recommendations that hold up under regulatory scrutiny, not just checkbox compliance.
- Deep experience across implantables, diagnostics, treatment devices, and cloud/SaaS-connected products
- Frameworks aligned to FDA, EU-MDR, NMPA, and PMDA requirements from day one
- Practical, prioritized findings, not generic vulnerability dumps
“Cybersecurity built into the product from day one avoids late-stage redesigns, streamlines regulatory approval, and lets manufacturers launch with confidence.”
— Aktriva team approach
Results our clients can point to
510(k) cleared — zero FDA questions
Aktriva was engaged to review all cybersecurity submission documentation for a new-generation device, aligning it with current FDA standards and eSTAR requirements. The submission received 510(k) clearance with zero questions from FDA.
Cleared without additional questions, in record time
After the manufacturer received an FDA deficiency letter, Aktriva was engaged to redraft the submission documentation and create new supporting reports to meet FDA expectations. The resubmission cleared without additional questions, in record time.
Approved by FDA with zero cybersecurity issues
For a major redesign of an implantable device with mobile and cloud connectivity, shortly after Section 524B of the FD&C Act took effect, the complete cybersecurity submission package required for PMA approval, including security testing, was prepared across two submissions.
Latest from the team
The CVSS 4.0 Transition: What Medical Device Manufacturers Should Know Before July 2028
FDA's recognition of CVSS v4.0 sunsets CVSS v3.1 for medical device submissions on July 2, 2028 — what manufacturers need to do to stay compliant.
Aug 17, 2026Cybersecurity in Quality: FDA's Guidance on Computer Software Assurance
FDA's Computer Software Assurance (CSA) guidance changes how manufacturers should validate the computers and automated systems used in production and quality operations.
Sep 23, 2025This week's regulatory briefing
A weekly digest of regulatory changes, standards updates, and upcoming deadlines affecting medical device cybersecurity. Covering 17th August - 23rd August.
Aug 23, 2026Ready to secure your next submission?
Tell us where you are in the device lifecycle. We'll help you find the fastest path to a defensible, compliant product.