Built by the experts who helped write the FDA Cybersecurity Guidance and the HSCC Joint Security Plan (JSP). Medcrypt Delivers Proven Results: 250+ Projects, 80+ Satisfied Clients, and 20 of the Top 50 Global MDMs.
(PRUnderground) November 17th, 2025
Medcrypt Inc., the leader in medical device cybersecurity, today announced the launch of Medcrypt Security Intelligence, the industry’s first expert-enhanced software solution for assessing, benchmarking, and advancing cybersecurity program maturity across the medical device lifecycle.
With more than 250 successful projects, 80+ satisfied clients, and a 100% FDA submission approval rate for cybersecurity elements, Medcrypt is the only company that addresses any cybersecurity findings or follow-up questions from the FDA at no additional cost – ensuring every supported submission achieves full approval. Its success stems from the same experts who helped write the FDA Cybersecurity Guidance and the HSCC Joint Security Plan (JSP), the foundational frameworks shaping today’s global medical device cybersecurity implementation framework.
With Section 524B of the FD&C Act changing the FDA mandate on cybersecurity and the global push for standards harmonization, Medical Device Manufacturers (MDMs) must now demonstrate measurable cybersecurity maturity across the product lifecycle to achieve and maintain compliance and market access. At the same time, hospital systems are raising expectations by increasingly including cybersecurity in their procurement processes, demanding verifiable proof of security readiness before purchase. Medcrypt’s recent Whitepaper, Cybersecurity Under Pressure – How Regulatory and Healthcare Buyer Expectations Are Reshaping the Medical Device Landscape, highlights how this dual pressure from regulators and buyers is reshaping the market.
From Proven Results to Purpose-Built Intelligence
Secure by design isn’t just Medcrypt’s philosophy – it’s the foundation of every solution. Our Security Intelligence solution transforms fragmented security program data into actionable insights, helping MDMs evolve from reactive compliance to proactive cybersecurity management.
Key capabilities include:
- Security Insights Dashboard: Central command view of security program maturity, assessing key activities such as threat modeling, vulnerability management, cryptography gaps, and general regulatory readiness.
- Benchmarking and Maturity Assessment Tools: Proprietary model that evaluates MDMs security program posture based on 12 representative industry frameworks, guidances, and standards ( such as FDA Cybersecurity Premarket Guidance, IEC 81001-5-1, ISO 14971, and HSCC Joint Security Plan v2 (JSP2)).
- Regulatory Evidence Engine: Collects and maps artifacts needed for submission (e.g., Software Bill of Materials, threat models, cryptographic controls documentation) to aid FDA and global regulatory reviews.
- Expert Guidance Overlay: Direct access to Medcrypt’s regulatory and product security experts for interpretation, prioritization, and multi-year roadmap planning.
- Quantify Financial Risk: Understand the potential business impact of security gaps and justify appropriate investments to mitigate risks.
Led by the Experts Defining the Field
Medcrypt’s team represents the industry’s deepest bench of regulatory, technical, and product security expertise. Collectively, they have authored key industry frameworks, reviewed hundreds of regulatory submissions, and guided the largest medical device manufacturers through evolving FDA expectations.
This unparalleled experience allows Medcrypt to translate regulatory complexity into measurable action, helping manufacturers strengthen their cybersecurity posture and bring safer products to market faster.
“Medical device manufacturers are being asked to prove that their security lifecycle processes are mature and hold up against regulatory scrutiny, by both regulators and customers,” said Mike Kijewski, CEO of Medcrypt. “Our people are what make Medcrypt different. Our team includes former FDA reviewers who helped write the current regulations. Medcrypt Security Intelligence turns that expertise into actionable intelligence, giving security, quality, and regulatory teams a common source of truth to demonstrate compliance, reduce risk, and ultimately deliver safer, more resilient products to patients.”
The launch caps a milestone year for Medcrypt, marked by 50% year-over-year customer growth and expansion into 15 of the top 25 global MDMs.
Since the FDA’s eSTAR and 524B enforcement took effect, 100% of Medcrypt’s inbound leads have been driven by these new mandates, a clear sign that enforcement is accelerating manufacturers’ adoption of robust cybersecurity programs and turning compliance readiness into a competitive differentiator.
To learn more about Medcrypt and Security Intelligence, visit www.medcrypt.com.
About Medcrypt
About Medcrypt
Medcrypt partners with healthcare technology companies to secure connected medical devices across their entire product lifecycle— from design and development to post-market monitoring and FDA submissions. Medcrypt’s offerings combine cybersecurity software, including cryptography infrastructure, SBOM, and vulnerability management, with a curated advisory team of engineers and global regulators to assess security maturity, guide remediation efforts, and align cybersecurity investment to maximize ROI.
Founded in 2016, Medcrypt was among the first to recognize that cybersecurity must be built into medical device design—not bolted on. Medcrypt has helped leading manufacturers navigate increasing FDA scrutiny, address submission deficiencies, and implement long-term security strategies that protect patients and accelerate innovation.
Backed by $36 million in funding from Johnson & Johnson Innovations, Intuitive Ventures, and Dexcom Ventures, Medcrypt continues to set the standard for medical device cybersecurity. Learn more at www.Medcrypt.com.
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Original Press Release.