Don't Let CSV Slow Down Medical Device Innovation
Automate risk assessments, streamline CSA and CSV processes, run only the testing that matters, and release quality software faster.
The Traditional Burden of CSV in Medical Devices
Paper-heavy validation. Documentation overloads your team and repetitive revalidation consumes valuable time.
Reactive Change Control. Every system update triggers redundant testing and approval cycles, costing more time and money.
Fragmented traceability. Disconnected systems obscure visibility and delay investigations.
Compliance at the cost of innovation. Slow, manual CSV processes extend time–to-market for critical devices.
Traditional CSV Can’t Keep Up
Traditional validation treats every system as high risk, regardless of its actual impact on product quality. The FDA’s Computer Software Assurance (CSA) guidance addresses this by replacing documentation-heavy processes with risk-based assurance focused on intended use and patient safety.
ValGenesis VLS is the first AI-enabled, single platform built to digitalize how medical device and MedTech manufacturers execute CSV and CSA.
Whether validating enterprise platforms, QMS software, or production systems governed by the FDA’s Computer Software Assurance for Production and Quality System Software guidance, ValGenesis delivers a compliant, scalable, and digital-first approach aligned with FDA software validation requirements and ISO 13485.
Advancing CSA with ValGenesis
ValGenesis Validation Lifecycle Suite transforms CSA for Medical Devices:
- 50% Faster Validation Cycles.
Shift from scripted testing for every system to risk-based assurance aligned with intended use and software impact. Automate protocol creation and execution within a compliant framework (FDA CSA guidance, ISO 13485, GAMP 5). - 30% Reduction in Validation Costs.
Eliminate manual rework and redundant testing through automation and reusability. Leverage vendor test evidence, digital traceability, and centralized validation assets to scale assurance across systems without adding headcount or compromising compliance. - 90% Less Audit Prep Time.
Every validation activity is digital, time-stamped, and version-controlled—ready for FDA or Notified Body inspections at any moment.
ValGenesis enables medical device and MedTech manufacturers to adopt risk-based validation and software assurance for medical devices, maintaining full compliance with FDA requirements for software validation, ISO 13485, and 21 CFR 820.
Trusted by
Customer Testimonials
We chose ValGenesis because they were a known and trusted vendor. We had limited time and resources, and we knew the quicker we could implement the solution, the sooner we’d start realizing value from it.
Joshua Pelina
Validation Engineer
We used ValGenesis’ vendor testing documentation because it was thorough, and it saved us a lot of time. We estimate saving 100 hours of work, which we reallocated to other parts of the project like training.
Raghav Mathur
Senior Validation Engineer
Used By Life Sciences Leaders Worldwide
Validation
Lifecycle Suite
AI-Powered Validation.
From Planning to Execution.
iVal
Supercharge validation with ValGenesis iVal™. AI-powered authoring, automated execution, live anomaly flags, and bulletproof traceability slash cycles by up to 80% and cut observations by 90%. From CQV to CSA, you’ll be audit-ready and market-ready faster than ever. iVal takes digital validation to the next level.
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iClean
Halve cleaning validation timelines and wipe out manual math with ValGenesis iClean™. Automated MACO calculations, ADE-aligned limits, 2D/3D equipment maps, and rule-driven workflows deliver digital, inspection-ready files across all sites. Standardize globally, flex locally, and gain real-time oversight - discover iClean today.
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iOps
Leave paper logbooks behind with ValGenesis iOps™. Mobile, QR-enabled forms capture every use, cleaning, and calibration event in real time; automated reviews, deviations, and alerts seal compliance gaps. Achieve 100% traceability, trim documentation labor by 70%, and connect ops to quality with iOps today.
Learn MoreReady to Stop Bleeding Hours and Dollars on Validation—and Breeze Through Audits?
Book a 15-minute demo and watch ValGenesis cut your CQV timelines.