Medical Device Software Development
Developer-first tooling for regulated software
Use your favorite DevTools and open-source software while automating compliance and traceability
Medical Device Compliance Software
R&D leaders in medical device software must quickly develop safe, validated software.
Expanding complexity emerges from the use of dozens of DevTools, thousands of types of open-source software, AI/ML, and microservice architecture. Managing this complexity while keeping developers productive at scale is an immense challenge.
Release Delays
The burden of highly manual release documentation can delay software releases, impacting the ability to quickly bring products to market and losing a competitive edge.
Compliance Burden
Navigating stringent regulatory requirements often leads to developers spending time on compliance and not working on the code. R&D leaders must navigate the validated use of AI, cloud-based tools, and off-the-shelf software.
Developer Attrition
When devs can’t use their preferred DevTools, or need to leave these tools often to do documentation, they are more likely to leave. High attrition rates and the associated costs of onboarding new developers disrupt project timelines and continuity, further delaying product releases.
Resources for Medical Device Software Engineering Leaders
FDA-Grade Medical Device Software
Build safe, IEC 62304-compliant software faster without the burden of manual documentation
Use agile development processes and automation to control all changes and documentation with ease, letting you focus on what you do best: building software. Achieve time-to-value in hours rather than weeks or months.
Stay in your DevTools
Simply connect Ketryx to your current development tools.
Minimize attrition and resulting product delays -- teams can continue to use their preferred tools and workflows with little disruption
Developers can continue to use the tools they love without worrying about compliance
Empowers teams to deliver fast, safe software with built-in guardrails to ensure compliance
Automate documentation
Focus on development, not documentation. No more spending 60% of your time on documentation, reviews, and hand-offs. Reduce errors and time spent copying/pasting data between different systems and documents.
Ketryx documents your work automatically from DevTools, eliminating manual, error-prone cutting and pasting and freeing up engineers to focus on coding
Produce a submission-ready DHF automatically
Ketryx supports AI and cloud-based technologies and simplifies documenting SOUP
Establish traceability
Automatically trace user needs and design all the way through product development, release, and post-market surveillance. Generate audit trails from the source code without having to hunt down spreadsheets.
Prevent dangling items like requirements, risks, and tests directly in Jira and GitHub
Generate traceability matrices and other FDA-ready documentation with a few clicks
Quickly identify coverage gaps and see how all risks, specifications, tests, and requirements are connected across the SDLC
Streamline change management
Stop recording one change in many places. With Ketryx, changes are documented automatically from your DevTools.
Changes are automatically documented through a Part 11-compliant audit trail in Jira
No need to duplicate work, like recording changes across multiple documents, so your team can focus on more strategic priorities and less tedious work
Removing copy-paste processes means fewer possibilities for human error
Automate and trace tests
Embed continuous testing throughout your entire lifecycle for safer, faster product delivery.
Embed Verification and Validation (V&V) into your software lifecycle
Accelerate dev efforts with SOUP and OTS software tools with confidence that they meet FDA standards
Keeping up with hotfixes and patches is easier than ever
Track all testing phases in a consolidated, at-a-glance dashboard
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“The fewer tools that my developers have to worry about, the better, because they should be worrying about saving people's lives through 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.”
Allan Snippen
VP of Engineering at HeartFlow
Ketryx bridges the gap between R&D and Quality for higher productivity and enhanced collaboration.
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