Bringing AI-Powered Gap Analysis to Medical Device Security Compliance
At Ryden Solutions, we’re proud to announce that our platform now provides comprehensive support for the FDA’s Premarket and Postmarket Cybersecurity Guidance—a critical step forward for medical device manufacturers navigating today’s regulatory and risk landscape.
As cyber threats grow in scale and sophistication, the FDA has made clear: cybersecurity is not optional—it’s a core component of product quality and patient safety. With the recent rollout of Section 524B requirements and increasing enforcement around SBOMs, threat modeling, and lifecycle security management, companies must demonstrate a proactive, auditable cybersecurity posture across the entire device lifecycle.That’s where Ryden comes in.
Our platform now enables:·
- Automated gap analysis to FDA Premarket guidance (2023 Final Guidance)
- Postmarket risk assessments aligned with FDA recommendations on vulnerability management and coordinated disclosure
- Continuous readiness for regulatory scrutiny and inspections
- Full traceability of cybersecurity controls across design, development, and deployment
By integrating these critical requirements directly into our AI-powered compliance system, Ryden removes the guesswork—and the grunt work—of proving FDA-aligned cybersecurity compliance.
Whether you’re preparing a 510(k) submission, monitoring deployed devices, or responding to a threat bulletin, Ryden helps ensure that your cybersecurity program isn’t just documented—but fully in compliance.
This launch reflects our continued mission: making life sciences compliance faster, smarter, and always inspection-ready – taking customers from a reactive to a Proactive compliance stance.
If you’re a medical device manufacturer or regulatory consultant working with cybersecurity compliance, let’s talk. We’d love to show you how Ryden can eliminate audit burdens and raise your compliance game.