SOMERVILLE, MA – May 16, 2023 – Ketryx, the creator of the first connected lifecycle management software for MedTechs, today announced new usability and productivity updates to its flagship software.
Recent guidance from the FDA on cybersecurity, AI/ML, and increasing connectivity of healthcare has made it all the more challenging for MedTechs to balance compliance efforts with the speed and execution that modern software demands.
“Our objective in founding Ketryx is to help companies deliver life-changing innovations faster,” said Erez Kaminski, founder and CEO. “We’ve zeroed in on the complex FDA processes that slow and even preclude many MedTechs from entering the market in the first place. We see an urgent need to help manufacturers leverage their AI/ML and cloud-based environments to deliver their breakthrough products faster, more reliably, and at lower cost.”
Funded by MIT, Ketryx is the first and only software solution that unifies existing on-premise and cloud-based tools in MedTech environments to become a living part of the development process. From design to post-launch, Ketryx records data directly from the different systems used to build the product and automatically creates documentation for the FDA for traceability and compliance purposes. Teams can use the tools they love while eliminating tedious, error-prone copying and pasting of information back and forth between systems.
By overlaying built-in intelligence and AI onto safety-critical software environments, Ketryx helps MedTechs dramatically improve efficiency, process control, and traceability. For example:
- Security hotfixes simplify change management by making it easy to fix security vulnerabilities without disrupting workflows or documentation
- Curated milestones synchronize development tasks so that teams can only progress when all milestone requirements are met. Documentation is automatically generated that captures the latest version of the project for further traceability and control.
- Automatically generated design controls follow the latest FDA guidance and make it easy to track histories
“Without the use of such approaches as Ketryx, manufacturers are stuck using legacy, standalone tools, making it harder for teams to collaborate and create the modern and life-changing software solutions they are capable of building,” said Kaminski.
Ketryx is the first and only Connected Lifecycle Management software for MedTech that creates traceability across the application lifecycle. Compliant by design, Ketryx embeds guardrails to eliminate the manual, error-prone copying and pasting from traditional disconnected medical systems to reduce the risk of defects while delivering enhanced patient outcomes. Visit us at www.ketryx.com or view a demo at demo.ketryx.com.
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