Ketryx

“Vektor Medical has been through three audits, including one from a leading notified body in 2024. All auditors were amazed by the level of detail, linkage and control that is built into Ketryx. The auditors were especially impressed by the trace matrix dashboard and risk management module. Ketryx is an efficient and compliant solution for medical device software development.”

“Overall we’ve been very happy relative to our previous workflow. Ketryx lets us get a lot more granular and more specific in terms of defining the configuration items. It maps much better onto our software development workflow and processes.”

“Ketryx AI is the most scalable approach we’ve used for regulated product development. It lets our teams make frequent, safe changes while staying continuously audit-ready, without relying on linear headcount growth or stopping teams for compliance exercises.”

“Ketryx empowered Nutrino to accelerate the adoption of OTS software and SOUP, ensuring confidence in our ability to proactively identify high-risk components and address potential issues early in the premarket submission cycle. This streamlined SDLC process has enabled us to deliver innovative and safe diabetes solutions much more rapidly.”

“Regulatory readiness for us means compliance by design: a QMS that’s inherently built into how the company operates, not an add-on. Ketryx enabled us to build a QMS smart enough to apply the strictest processes only where they’re truly needed.”

“Delivering quickly is core to our mission because faster releases mean better health outcomes for our users. Ketryx is the only partner we found that gave us the ability to maintain our velocity while achieving medical-grade quality.”

“Ketryx allowed us to simplify a few process steps, like approvals and design reviews. We have an overall better process compliance with Ketryx, and we rely very much on the predefined workflow that is equivalent to ISO 62304. That helps us because we don't have to invest so much effort in configuring that ourselves.”

“Ketryx is becoming an intrinsic part of every piece of software we build. It’s not another tool we have to use on the side to be compliant with standards; it’s just a natural way of developing high-quality software with excellence.”

“The fewer tools that my developers have to worry about, the better, because they should be worrying about saving people's lives with AI through our products. They don't need to be worrying about yet another tool to make sure that they can get our technology out there.”

“Ketryx supports our system of systems architecture really easily out of the box. We were able to migrate our monolithic ecosystem into a single project and break it down into a desired state just within a couple of days. Ketryx delivered that because it was designed to scale. That was a huge plus.”

“I used a traditional ALM in the past and it didn’t have the traceability I needed, especially tracing from my test executions and results. It also created duplicate work since I needed to go update my work there every time I completed a task. Ketryx updates itself as I’m working in Jira and GitHub. This tighter integration into our current tools helps us be more productive and release faster.”

“Ketryx has allowed us to channel our hardware and software engineers’ existing set of development, testing, and documentation practices directly into the generation of compliant documentation with minimal additional burden. This has allowed us to remain agile while delivering high-quality products.”

““The Ketryx software enables us to scale our innovation with quality through a single streamlined software development lifecycle, helping us expedite releases.””

“Ketryx gave us a scalable way to manage product cybersecurity risk. We’re running assessments more frequently, prioritizing the right issues, and improving our overall security posture without increasing effort.”