Ketryx Lifecycle Management for Jira

We are a small team working to make a public-health impact. Ketryx has helped us comply with our regulatory requirements without having the FTE typically required to meet those requirements manually. The JIRA based nature of Ketryx has allowed us to insert Ketryx into our existing processes. It has helped us design and create better software by ensuring we meet full traceability requirements. I would highly recommend for any organization developing SAMD.

Ketryx has greatly improved our process reliability. The seamless integration into our workflow ensures compliance without additional effort. The automated traceability and risk management has streamlined our development process and made documentation much easier. Highly recommended for teams in regulated industries!

Ketryx exceeded our expectations, enabling our relatively inexperienced team to set up an IEC62304-compliant process from scratch and pass an NCR audit within just 3 months. Ketryx simplified IEC62304 implementation, ensuring we met all required standards. Its standout traceability features were invaluable during our audit, helping us confidently demonstrate compliance and boosting the auditor's confidence in our processes. Additionally, Ketryx's ability to generate technical documentation on the fly saved us countless hours. Instead of manually compiling reports, we effortlessly produced comprehensive, up-to-date documentation with minimal effort. Ketryx has been critical to our success, and we highly recommend it to teams looking to streamline software development workflows and navigate regulatory requirements with ease.

At DeepHealth, we have had the privilege of partnering with Ketryx as we transitioned our product portfolio into their software platform. Throughout this process, Ketryx has demonstrated exceptional customer service and provided invaluable guidance, ensuring a seamless integration experience. The Ketryx platform has significantly enhanced our operational efficiency by streamlining processes that previously required manual duplication for Quality-related documentation. By eliminating redundancies, the software has enabled our team to focus their efforts on engineering tasks that drive innovation and product development. This optimization has not only expedited the release process but also delivered measurable value to both our Quality and Engineering teams. The result is a more collaborative and effective workflow, reinforcing our commitment to delivering high-quality solutions to our stakeholders. Ketryx's expertise and dedication to customer success have made them an indispensable partner, and we look forward to continuing our collaboration to achieve even greater operational excellence.

Ketryx has been a great partner in providing a tool for teams to navigate how to properly develop medical devices, especially solutions including software, with relevant records needed to meet different standards, e.g. IEC 62304, and compliance requirements. Additionally, they have great educational materials that we can leverage to share with internal teams. Last, they could provide relevant comprehensive validation packages with new SW releases that are commonly required in the GxP environment, so ameliorate part of the compliance efforts from us.