Vektor Medical - Ketryx
How Vektor Medical Accelerated Documentation Time by Over 60% with Ketryx
Vektor Medical is a MedTech innovator specializing in AI-powered solutions for cardiac care. The company focuses on developing groundbreaking software that provides actionable insights physicians can use to improve diagnosis and treatment planning for cardiac arrhythmias. Ketryx transformed Vektor Medical’s software development and documentation processes, enabling them to use a system of systems architecture, stay compliant, and develop faster.
Impact
60%
Reduction in documentation cycle time
$25 million
Series A funding
3
Audits completed
Industry
MedTech
Device Type
AI-Enabled, Cardiovascular
Tech Stack
Jira, GitHub
Customer pain points
Documentation and traceability slowed development
As an AI-first company, Vektor Medical uses modern development tools, but like most companies in the industry, faced challenges creating compliance documents efficiently, managing change, and ensuring accurate traceability.
- Slow Documentation Process: Documentation cycles took 8 weeks, often delayed by last-minute changes and manual data synchronization with Word documents and Excel spreadsheets.
- Traceability Challenges: A lack of granular traceability led to gaps in traceability and redundant links between requirements, specifications, and tests.
- Manual Change Management: Manual processes made it difficult to ensure all changes were accurately documented and approved.
The Ketryx solution
Streamlining change management
Vektor Medical sought a solution to streamline SDLC management and selected Ketryx to achieve the following objectives:
- Automated Trace Matrix: Ketryx’s visual traceability helped identify gaps by clearly linking requirements, specifications, and tests, with tools for real-time tracking of trace matrix completeness.
- System Architecture Graphs: Ketryx provided clear visualization and organization of Vektor’s microservice architecture, simplifying complexity.
- Streamlined Change Management: Simplified handling of updates and approvals, reducing the burden of updating documentation with last-minute changes.
Business Outcomes
Accelerating documentation, powering innovation
With Ketryx, the Vektor Medical team quickly realized several key benefits:
- 60% Faster Documentation Cycle: Reduced documentation time from 8 weeks to 3 weeks per release.
- Enhanced Traceability: Increased trace matrix granularity, ensuring comprehensive coverage of requirements and tests.
- Improved Compliance Confidence: Documentation clarity and completeness made regulatory submissions easier.
- Increased Efficiency: Enabled a small team to identify gaps, visualize open items, and address them proactively with automated tools.
- Accelerating Innovation: Eliminated redundant traceability linkages and streamlined requirements management, freeing up time for more strategic tasks.
"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."
Mihir Naik
Senior Director, Quality