About
Ketryx is a subscription-based SaaS platform for medical device software compliance and application lifecycle management (ALM). It enables teams to generate FDA-compliant SBOMs in minutes via scanning or SPDX import and is built around the Ketryx Compliance Framework. The product explicitly targets regulatory and quality standards including IEC 62304, GMP, ISO 13485, EU MDR, and CFR 21 Part 820/11. The site highlights “Agentic AI for FDA Compliance.” Ketryx is sold as monthly, annual, and multi-year subscriptions with multiple options based on company size, stage, and products needed. The vendor states validation evidence and documentation are provided upon request and asks buyers to contact sales to learn more.
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ICS - Integrated Computer Solutions provides software development and cybersecurity services for regulated and mission-critical markets. The record references a developer tool and product named SBOMGuard for Software Bill of Materials (SBOM) and SBOM Vulnerability Management, with language such as “Safeguard Your Medical Devices” and “Identify Known Vulnerabilities.” ICS describes cyber experts who help safeguard software powering connected medical, industrial and consumer devices, and offers full-lifecycle product development, cloud and web solutions, and UX-driven custom cross-platform software. The company positions these capabilities for regulated markets and medtech innovators seeking device design and software safety support.
Threat Detective is SBOM and vulnerability management software for medical device teams. It imports and validates CycloneDX and SPDX SBOMs, identifies vulnerabilities using NVD, GitHub Security Advisories, and OSV, prioritises findings using CVSS, EPSS, and CISA KEV, and records exploitability, remediation, and mitigation decisions with an auditable history. It turns that vulnerability analysis into submission-ready cybersecurity evidence for medical device regulatory workflows, including FDA premarket submissions, and supports VEX generation. Continuous monitoring then tracks active device and software versions for newly disclosed vulnerabilities throughout post-market surveillance.