NEWS & Events!
Quality Systems and Regulatory Compliance: Stay ahead with curated industry
Timely insights and global perspectives from the experts shaping the future of quality and compliance.
EUDAMED Officially Mandatory!
EUDAMED (European Database on Medical Devices) became officially mandatory with the implementing act published on 26 November 2025. The key compliance deadlines are May 2026 and November 2026.
EUDAMED is designed to increase transparency, traceability, and patient safety across the EU medical device market.
Upcoming ISO 9001:2025/2026
The upcoming ISO 9001 revision (ISO 9001:2025/2026) will introduce significant updates around sustainability, risk management, leadership, and organizational culture. The final publication is expected in September 2026, with a three‑year transition period for certified organizations.
Transition period: ~3 years (until September 2029)
ISO 10993-1:2025 is the newly published 6th edition of the biocompatibility standard for medical devices, released in November 2025. It introduces a stronger risk-based, fecycle-oriented approach, requiring manufacturers to integrate biological evaluation fully into ISO 14971 risk management processes.
Biocompatibility is no longer a static checklist but a dynamic, risk-managed process.
Upcoming Webinars: Empowering Quality Systems and Regulatory Compliance!
Whether you're preparing for certification, refining your QMS, or navigating international submissions—these webinars are your gateway to clarity, confidence, and strategic growth.
Compliance to Confidence: Navigating FDA QMSR & Beyond
FDA QMSR Demystified: What You Need to Know Before 2026
Global Ready: Regulatory Insights for Market Expansion
Certification Success: Planning, Training & Global Body Selection
Quality Unlocked: Strategies for Small Manufacturers
Building Audit-Ready Systems: Internal & Supplier Oversight