Built by Cliniciansand Security Engineers
We started MShield because the tools that protect enterprise software were never designed for the realities of medical device development — FDA timelines, IEC standards, and the clinical stakes that come with connected care.
Accuracy vs. legacy rule-based scanners
Faster FDA 510(k) cybersecurity documentation
Faster patch cycle vs. manual triage workflows
R&D through post-market surveillance lifecycle
Make Clinical Cybersecurity Systematic
Every connected device deserves clinical-grade security — not as an afterthought, but as a foundation.
Medical devices are increasingly software-defined, networked, and targeted. Yet the cybersecurity workflows most device makers rely on are manual, fragmented, and disconnected from the regulatory evidence trail that FDA and EU MDR demand.
MShield exists to change that. We built a platform that treats cybersecurity as a first-class engineering discipline — one that generates compliance artifacts automatically, integrates with the device lifecycle from R&D through post-market surveillance, and gives regulatory teams the evidence packages they need without weeks of manual assembly.
From the Operating Room to the Platform
MShield was founded in 2019 by a team that had spent years on both sides of the problem — clinical engineers who had watched device recalls unfold from unpatched vulnerabilities, and security researchers who had probed the attack surface of implantables and IoMT systems firsthand.
The founding insight was simple: the cybersecurity frameworks that existed were written for enterprise IT, not for devices with 10-year lifecycles, locked firmware, and patients depending on them. We needed something purpose-built.
Today, MShield is trusted by device makers across SaMD, implantables, diagnostic systems, and IoMT — from pre-submission through post-market surveillance — in the US, EU, and APAC markets.
Principles We Build By
Clinical stakes first
Every design decision starts with the patient. Security failures in medical devices are not abstract — they have clinical consequences we take personally.
Regulatory honesty
We don't oversell compliance. We help device makers build the evidence that regulators actually need — no more, no less.
Engineering rigor
Cybersecurity should be as systematic as design verification. We build tools that make rigorous security the path of least resistance.
Transparency by default
Our customers see exactly what MShield found, why it matters, and what evidence was generated. No black boxes.
Ready to See MShield in Action?
Schedule a personalized demo with our clinical cybersecurity team.