Case study · FDA Cybersecurity Readiness
Medcrypt Transforms SBOM Management: 90% Faster Vulnerability Review for Global MDM
From Manual Bottleneck to Automated Intelligence
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What this whitepaper covers
As global regulators tighten their cybersecurity expectations, medical device manufacturers (MDMs) face unprecedented scrutiny across the entire product lifecycle.
This joint whitepaper from Medcrypt and the Johner Institute provides a comprehensive roadmap for achieving cybersecurity compliance across multiple jurisdictions, including the U.S. FDA, EU MDR/IVDR, and international standards such as IEC 81001-5-1.
The paper clarifies how manufacturers can integrate security practices into their quality management systems (QMS) and software lifecycle processes, and provides side-by-side mappings of global regulatory expectations. It also includes real-world examples of FDA and EU market approval rejections caused by insufficient cybersecurity documentation and testing, offering lessons learned and practical remediation strategies.
Why it matters
The regulatory and product context
Cybersecurity is now a decisive factor in regulatory approval for medical devices. Both the FDA and European Notified Bodies have begun rejecting submissions solely for cybersecurity shortcomings — including missing SBOMs, inadequate threat modeling, or lack of postmarket surveillance planning.
This whitepaper helps manufacturers navigate these heightened expectations by:
- Mapping requirements from FDA Premarket Guidance (Sept 2023), EU MDCG 2019-16, and IEC 81001-5-1.
- Explaining how to integrate these requirements into product design, testing, and postmarket activities.
- Providing actionable checklists and examples of regulator feedback to help teams prepare for audits and avoid common mistakes.
Key insights
What you’ll take away
- Global regulatory bodies are aligning on lifecycle-based cybersecurity frameworks, increasing the need for cross-functional coordination.
- The most common causes of market approval rejection include missing documentation, lack of traceability, and unqualified personnel.
- IEC 81001-5-1 has become the unifying backbone for both U.S. and EU cybersecurity expectations.
- Integrating cybersecurity into QMS and design controls early reduces rework, delays, and rejection risk.
- Medcrypt and Johner Institute provide frameworks and tooling to help manufacturers operationalize compliance efficiently.
Who should read this
- Regulatory Affairs and Quality Leaders: Aligning U.S. and EU cybersecurity documentation and QMS processes.
- R&D and Engineering Teams: Implementing secure-by-design methodologies across development phases.
- Cybersecurity and Risk Professionals: Mapping lifecycle controls to IEC 81001-5-1 and FDA SPDF expectations.
- Executives and Program Managers: Building scalable, audit-ready cybersecurity programs for global submissions.
Related resources
Go deeper on the topics in this whitepaper with Medcrypt analysis and real device programs.
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