2025 State of Validation

Validation Strategies in Medical Devices

NAVIGATING COMPLEXITY AND AUDIT PRESSURES

Validation teams in the medical device sector face unique challenges: lean staffing, high regulatory scrutiny, and growing audit expectations. This whitepaper highlights how medical device manufacturers are adapting, with strategies for efficiency, compliance, and digital transformation.

Key Takeaways:

69% of medical device teams report rising workloads, while team sizes remain lean.
Only 16% have fully adopted CSA, revealing significant opportunity for improvement.
Audit readiness is the #1 challenge — surpassing compliance burden and efficiency.
Digital validation adoption is accelerating, yet 62% still lack system integrations.