New Product Launch, Enterprise Momentum, and Industry Partnerships Fuel Medcrypt’s Growth in 2025
Medcrypt, the leading provider of proactive cybersecurity solutions for medical devices, announced today a major milestone in its continued growth, fueled by new product innovation, strategic partnerships, and increasing regulatory pressure for secure-by-design medical technologies.
The company introduced its new Medical Device Product Security Intelligence Platform, currently available in early access, designed to help medical device manufacturers assess their product’s security posture, identify gaps, quantify cybersecurity risk in dollar terms, and generate cost-aligned remediation plans in minutes. Designed for both premarket and postmarket teams, the platform empowers cross-functional teams to identify and address product risks, prioritize investments, align security strategy with industry standards, and with customer and regulatory requirements – all while accelerating time to market through a strategic, end-to-end cybersecurity roadmap.
This launch reinforces Medcrypt’s integrated approach to medical device cybersecurity – combining scalable software with expert regulatory consulting to help manufacturers meet security and compliance goals at every stage of the product lifecycle.
“Cybersecurity is no longer optional or reactive – it’s a strategic function that impacts compliance, trust, and business outcomes,” said Mike Kijewski, CEO of Medcrypt. “We’ve seen record demand from manufacturers that need a faster, more defensible way to build and maintain product security. Our new platform helps them do exactly that – with a tool that’s fast, actionable, and built for how device teams actually operate.”
Momentum Across Platforms and Services
- Medcrypt’s software and services are now used by 8 of the top 10 global medical device manufacturers
- Completed 250+ product security advisory and software projects in the past 12 months
- Achieved a 100% submission success rate for cybersecurity documentation submitted to the FDA
- First company to offer a cybersecurity submission guarantee, providing expert support until the cybersecurity section of a submission is accepted
- Expanded strategic collaborations with regulators, standards bodies, and connected device innovators.
As cybersecurity requirements from the FDA, EU, and other global regulators continue to evolve, and health delivery organizations mature in their expectations of vendors, Medcrypt ensures that medical device manufacturers are not only compliant – but efficient, aligned and future-ready.
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