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.
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
Working with medical device and health IT manufacturers wherever they're building.
Who you'll work with
Ramakrishnan Pillai, CISSP, CRISC
Principal Consultant
20+ years in global cybersecurity consulting, with leadership roles at LivaNova, Elekta, Coalfire, and Cisco. Focused on building product security programs, FDA/MDR submissions, and legacy medical device security initiatives — all in service of patient safety and data privacy through secure innovation.
Brindusa Curcaneanu
Cybersecurity, Quality & Regulatory Advisor
25+ years across medical devices, pharma, and biotech, specializing in AI-enabled devices, regulatory compliance, design controls, and risk management. Experienced with ISO 13485/62304/14971, FDA QSR, EU MDR, and MDSAP. Co-author of HSCC's AI Secure-by-Design guide and mentor with Women in Cybersecurity (WiCyS).
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.