Cybersecurity services for medical devices
Empowering medical device manufacturers to build cyber-resilient solutions — from concept through post-market surveillance.
Security expertise built for regulated devices
Three focus areas that cover the full lifecycle of a connected medical device — from first threat model to post-market monitoring.
Regulatory Compliance Consulting
Guidance through complex global cybersecurity regulations — FDA, EU MDR, and beyond — so your submissions clear the bar the first time.
Learn more →Security by Design Services
Cybersecurity embedded into every stage of the device lifecycle, from architecture and threat modeling through deployment and support.
Learn more →Application Security & Testing
Automated scanning and expert-led penetration testing that surfaces real, exploitable risk — not just findings that pad a report.
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
Latest from the team
Cybersecurity 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 26, 2025 Supply Chain RiskCISA Publishes Draft Update on SBOM Minimum Elements
CISA's 2025 draft update to the Software Bill of Materials minimum elements builds on the 2021 NTIA standard, with implications for medical device supply chain transparency.
Sep 12, 2025 RegulationsMicrosoft Windows 10 End of Life: What It Means for Medical Devices?
Microsoft ended Windows 10 support on October 14, 2025 — a decade-long lifecycle closing that raises cybersecurity and regulatory concerns for connected medical devices still running it.
Sep 9, 2025Ready 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.