MEDICAL DEVICE TRENDS
WORKLOAD IS RISING — BUT MOST RECORDS ARE STILL ON PAPER
The 2026 State of Validation study captures insights from medical device validation professionals worldwide. 81% report rising validation workloads, and full digital validation tool adoption has doubled year-over-year — yet paper persists across core record types, and the compliance burden remains the top challenge for validation teams. This whitepaper delivers a practical framework for closing the paper-digital divide, proving ROI, and building continuous audit readiness.
KEY TAKEAWAYS:
Why workload is climbing across medical device validation teams
Why the paper-digital divide remains a hidden cost center
How digital validation tool adoption doubled — and the ROI it delivers
Why AI trust must be earned, not assumed in the medical device industry
How Kneat Gx turns compliance pressure into competitive advantage