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Discover a new way to develop regulated software

Creating and managing the lifecycle of a medical application is expensive, time-consuming, and error-prone. But what if it didn't need to be?

Share your details to download the The Cost of Quality White Paper

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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.

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Ketryx for Enterprises

As an established MedTech company, you’ve brought better quality healthcare to deserving patients. You’ve got your SOPs and staff in place and issue regular releases while maintaining change control processes.

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Maximize efficiency throughout all aspects of your product lifecycle

But what if you could squeeze more efficiency and profitability out of the development process, freeing your staff to be more strategic? What if you could bring more releases to market without adding resources or cost?

Optimize your existing investment

Ketryx connects and traces all tasks, activities and workflows throughout the product lifecycle from design to post-launch. As an overlay, Ketryx doesn’t replace your existing QMS or dev tools – it connects them -- eliminating error-prone cutting and pasting from previous silos.

Stay on top of new regulatory guidance

As new guidance is issued on critical areas such as security, AI, and ML, we make it easy for you to stay ahead of new requirements. Our expert team continuously releases updates that anticipate new requirements with built-in intelligence.

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

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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

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