Security expertise, built for regulated devices
We empower medical device innovators with expert cybersecurity support that ensures regulatory compliance, strengthens patient and customer trust, and accelerates time to market.
"At Aktriva, our mission is to empower medical device innovators with expert cybersecurity support that ensures regulatory compliance, strengthens patient and customer trust, and accelerates time to market."
Cybersecurity embedded, not bolted on
We embed cybersecurity practices into product development to safeguard patient safety and privacy — helping manufacturers avoid late-stage redesigns, streamline regulatory approval, and launch with confidence.
Our team has worked across oncology, neuromodulation, implantables, diagnostics, and cloud/SaaS-connected products, giving us a practical view of what regulators and customers actually expect from a submission.
Based in Austin, TX
Supporting medical device and health IT manufacturers globally.
Results our clients can point to
510(k) cleared, no FDA questions
Aktriva was engaged to review and update all cybersecurity documentation for a new-generation device, aligning it with current FDA standards and eSTAR requirements. Device 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.
PMA approved, no cybersecurity deficiencies raised
A class III medical device with mobile and cloud connectivity underwent a major redesign 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.
Active in the industry, not just advising on it
Aktriva is a member of the Healthcare and Public Health Sector Coordinating Council (HSCC) Cybersecurity Working Group, contributing directly to the industry frameworks manufacturers rely on — including the Joint Security Plan and Managing Legacy Technology Security guidance.
Aktriva is also a member of AAMI (Association for the Advancement of Medical Instrumentation), a leading organization in the development of medical device and health technology standards, including TIR57, TIR97, and SW96.
See the frameworks we've helped write →
We're growing our team
We're always interested in hearing from experienced medical device cybersecurity, regulatory, and quality professionals who want to work directly with manufacturers on high-impact, patient-safety-driven work. If that's you, reach out and tell us about yourself.
Let's talk about your device
Whether you're pre-submission or already in the field, we can help you find the right next step.