Whitepaper · FDA Cybersecurity Readiness
Navigating Cybersecurity Compliance: A Lifecycle Approach for Medical Device Manufacturers
Aligning FDA, EU MDR/IVDR, and IEC 81001-5-1 Requirements for Secure Market Approval
Read whitepaperThe Challenge
At a Glance:
Challenge:
Details:
A global medical device manufacturer struggled with labor-intensive SBOM management and vulnerability review processes consuming engineering resources without delivering strategic insights. Manual CVE analysis took weeks, preventing timely risk assessment and remediation prioritization. The team lacked automated workflows for bulk rescoring, data enrichment, and continuous monitoring — creating bottlenecks that delayed security decisions. Without validated KPIs demonstrating program value, leadership questioned continued investment in vulnerability management. The organization needed both operational efficiency improvements and business case validation to sustain their security program long-term.
The Solution
At a Glance:
AI-Driven Automation with Expert Review:
Medcrypt implemented vulnerability management as a service, combining AI-driven automation with expert manual review to dramatically accelerate SBOM processing while improving accuracy. The hybrid approach automated routine CVE screening, bulk rescoring, and data enrichment while leveraging human expertise for complex risk assessments and false positive elimination.
Program KPIs and Sustainable Governance:
Medcrypt established automated workflows integrating with the manufacturer's existing tools, eliminating manual data transfer bottlenecks. Beyond operational improvements, Medcrypt developed program KPIs demonstrating security ROI, providing leadership with quantifiable metrics validating continued vulnerability management investment and informing future resource allocation.
The Impact
Medcrypt's hybrid approach combined intelligent automation with expert validation, delivering dramatic efficiency gains while proving long-term program value to leadership.
Go deeper on the topics in this case study with Medcrypt research and analysis.
Whitepaper · FDA Cybersecurity Readiness
Aligning FDA, EU MDR/IVDR, and IEC 81001-5-1 Requirements for Secure Market Approval
Read whitepaperBlog · Tools & Processes
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