Redefine Regulatory Compliance in Healthcare Predictive Compliance. Safer

TL: DR AI is reshaping compliance : both industry and the FDA are accelerating adoption, making a validated, risk-managed use of AI essential. Enforcement is tightening for 2026 : With heightened scrutiny across drugs, devices, and a strong focus on systemic, lifecycle-wide risk management. Proactive, predictive compliance is gaining momentum : Unified regulatory intelligence helps organisations prevent surprises, reduce costs, and turn regulatory complexity into strategic ad

TL;DR Feb 2026 changes everything : FDA QMSR aligns with ISO 13485 and ushers in faster, tougher, more connected enforcement. Risk becomes the core of compliance : Risk intelligence must actively drive CAPAs, complaints, and decisions, not sit in documents. Predictive compliance wins : Real-time regulatory insight (incl. governed AI) separates proactive leaders from reactive laggards. FDA QMSR 2026: The Compliance Reset for MedTech As the Medical Device industry looks towards