Enterprise IVD Company - Ketryx
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From Three Months to One Week: How a Top 5 IVD Company Transformed its Software Release Cycle
A leading worldwide in vitro diagnostics company develops software-driven diagnostic systems used across clinical and laboratory settings globally. At that scale, the ability to release fast without compromising regulatory standards is a business requirement. Every release touches patient workflows, and every delay has downstream consequences.
After implementing Ketryx, the company reduced its end-to-end release cycle from three months to just one week, reduced documentation time by 55%, and eliminated more than half of its existing tooling costs. Engineering and quality teams that once spent release cycles catching up on compliance now reinvest that capacity in advancing the product.
Impact
Three months to one week
End-to-end release cycles
70%
Reduction in documentation time
50% +
Reduction in tooling costs
Industry
IVD
Device Type
Diagnostics + SaMD
Tech Stack
Jira, GitHub
Pain Point: Engineering was not the bottleneck. Compliance was.
Code was routinely wrapped and ready to push well before the release window opened. The delay lived in compliance, but the problem wasn't processes or standards. It was the tooling and processes meant to manage it:
- Tool proliferation created compliance gaps no one could see: Teams worked across separate systems with inconsistent adoption and inconsistent processes. The result was duplicated work, misaligned records, and elevated compliance risk accumulating in the gaps between platforms.
- Documentation ran at the back of every release: Every development cycle ended with a documentation sprint. QA and engineering time was consumed by cleaning up old releases instead of preparing for the next ones.
- Compliance issues surfaced when they were most expensive to fix: Gaps weren't visible until teams were already deep in the release process, when resolving them was slow, costly, and disruptive to future release timelines.
Solution: Quality built into existing workflows. No migration required.
Jira, GitHub, and other engineering tools were preserved. Ketryx overlaid the environment around them, embedding compliance infrastructure without requiring a platform migration.
- Compliance embedded at the point of work: Quality controls and traceability built directly into engineering workflows, with no new platform for engineers to learn or maintain.
- Real-time traceability across the full development stack: Requirements, risks, tests, and designs linked end-to-end across connected tools and ALMs.
- Automated evidence generation: Compliance documentation populated automatically from engineering activity.
Business Outcome: Their release cycle is 90% faster.
- 7 weeks to 7 days: 90% faster end-to-end release cycles came from embedding compliance into existing workflows and stopping the compliance rework that had been accumulating at the end of every cycle.
- 70% reduction in documentation time: Continuous traceability standardizes a baseline of regulatory readiness, so documentation no longer piles up between releases.
- >50% cost reduction in tooling: Staying in existing tools let the team consolidate their compliance stack without replacing what already worked.