Expert-Enhanced Cybersecurity Program Maturity Assessment for Medical Device Manufacturers
Medcrypt’s Security Intelligence evaluates your people, processes and documentation against our proprietary framework built by the same experts who helped author the FDA Cybersecurity Guidance and Joint Security Plan (JSP).
Drawing on insight from 250+ real submissions, 80+ client engagements, and a 100% FDA cybersecurity approval rate, the solution delivers a regulator-aligned snapshot of your security maturity.
It helps you identify where your program falls short, understand why, and focus resources on the actions that matter most - turning cybersecurity from a regulatory burden into a measurable business advantage. The result is a defensible, data-backed roadmap that enables faster approvals, smarter budgeting, and sustainable security maturity.
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Knowing the guidance isn't enough - You need to know how it's enforced.
Medical device manufacturers are under pressure to prove cybersecurity program maturity - not just claim it. Most models outline best practices, but don’t reveal how the FDA actually evaluates submissions.
At Medcrypt, we’ve seen both sides. Our experts helped write the Join Security (JSP) and FDA guidance, then supported hundreds of real-world submissions. We know where enforcement is intensifying, what deficiencies trigger hold letters, and which evidence convinces reviewers that your program is sound.
This isn’t another self-assessment. It’s a reality-based maturity evaluation informed by current FDA expectations - and a path to resolve issues before they become findings.
From Assessment to Action - Built on Standards, Powered by Experience
The Medcrypt Security Intelligence solution blends structured, standards-based assessment with the insight of experts who helped shape cybersecurity expectations. In just weeks, you’ll know where your program stands - and what to do next.
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Complete our proprietary 30-question evaluation informed by 12 global standards, frameworks, and guidance (including FDA, JSP v2, ISO 81001-5-1, IEC 62443, and AAMI SW96). Each question is validated by Medcrypt’s SMEs, ensuring your responses align with how the FDA and other regulators interpret maturity.
Our SME analyzes your responses to identify high and medium risk areas, then conducts a root cause analysis using your QMS evidence (e.g., 510(k) documentation). We identify why gaps exist, how to fix them, and what proof regulators expect.
We translate technical findings into financial terms - modeling the cost of inaction vs. cost to mitigate - so you can justify budget and prioritize by ROI.
You’ll receive a phased roadmap that identifies quick wins, regulatory must-haves, and long term investments 一 mapped to cost, feasibility, and business impact.
Faster Approvals. Smart Investments. Stronger Security.
Manufacturers who complete a Security Intelligence assessment gain clarity, confidence, and control. Our structured analysis delivers measurable outcomes that accelerate approvals and strengthen your entire product security program.
Key benefits include:
Avoid late-stage rework. Our insights - responsible for a 100% approval rate - prevent costly deficiencies.
Demonstrate compliance with the JSP2, IEC81001-5-1, AAMI SW 96 and more - with evidence traceable across your QMS.
Enforcing least-privilege access controls for users and devices
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A multi-year roadmap helps you phase remediation efforts, track progress, and plan spending strategically.
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Gain perspective from 250+ projects - seeing what FDA reviewers focus on, where they push back, and what they reword.
Built by the Authors - Informed by Approvals - Proven by Results
While other tools stop at checklists, Medcrypt Security Intelligence delivers an expert-interpreted, regulator-aligned evaluation informed by 250+ submissions and real enforcement outcomes.
Where MDIC’s model measures alignment, we measure effectiveness - analyzing how your program would actually perform under FDA review.
Every insight comes from lived experience across the world’s top manufacturers and global frameworks.
Download the one sheet for more on how the platform empowers product teams and executives to quickly benchmark their product security posture, quantify financial risk, and prioritize actionable improvements with clear budget insights.