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Develop Fast;
Stay Compliant

Ketryx is the first and only connected lifecycle management software for MedTech that unifies quality and R&D efforts to deliver safer, more innovative software up to 2-3x faster.

Ketryx significantly reduces the time and resources required to create and maintain SBOMs both pre- and post-market while minimizing risk.

Streamline documentation with actionable reporting

Generate an FDA-ready Software Bill of Materials (SBOM) directly from your source code and preferred tools in minutes

Comply with regulations around COTS, SOUP, and Off-the-shelf Software (OTS), and Open Source, like IEC 62304/GAMP 5 and CFR21 Part 11

Customized monitoring triggers alerts to ensure you’re using the latest and most secure versions of each software component

Gain peace of mind by detecting and rapidly mitigating security issues before they affect device performance

Easily identify and prioritize risk and associated dependencies. Quickly isolate problematic software applications and versions when known vulnerabilities are discovered.

Reduce time/resources spent on dependency management

Track tens of thousands of Open Source dependencies across multiple teams and existing quality, development, and lifecycle systems to ensure you meet critical development milestones

Leverage the speed advantages from off-the-shelf software without compromising safety

Gain peace of mind that you can safely leverage off-the-shelf software components while focusing your resources on developing life-saving patient solutions

Streamline documentation with actionable reporting

Generate an FDA-ready Software Bill of Materials (SBOM) directly from your source code and preferred tools in minutes

Comply with regulations around COTS, SOUP, and Off-the-shelf Software (OTS), and Open Source, like IEC 62304/GAMP 5 and CFR21 Part 11

Customized monitoring triggers alerts to ensure you’re using the latest and most secure versions of each software component

Gain peace of mind by detecting and rapidly mitigating security issues before they affect device performance

Easily identify and prioritize risk and associated dependencies. Quickly isolate problematic software applications and versions when known vulnerabilities are discovered.

Reduce time/resources spent on dependency management

Track tens of thousands of Open Source dependencies across multiple teams and existing quality, development, and lifecycle systems to ensure you meet critical development milestones

Leverage the speed advantages from off-the-shelf software without compromising safety

Gain peace of mind that you can safely leverage off-the-shelf software components while focusing your resources on developing life-saving patient solutions

Demo

Are You Building Medical Software?

Ketryx is the first and only connected lifecycle management software designed to enable MedTechs to take advantage of Cloud-based tools while maintaining FDA, cGMP, and ISO compliance