The U.S. Food and Drug Administration (FDA) has published “Cybersecurity in Medical Devices: Quality Management System (QMS) Considerations and Content of Premarket Submissions” updated guidance issued 3 February 2026. This guidance replaces the 2025 edition and...

The FDA's updated compliance program manual page: https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/center-devices-and-radiological-health-cdrh-compliance-programs

Feb 02, 2026 marks the end of the 2‑year transition and the beginning of a globally aligned quality era, harmonized with ISO 13485:2016 👉 As of TODAY, all FDA-regulated companies must comply. If you manufacture, design, or distribute FDA-regulated medical...

EMA Releases ICH M11: A New Era for Clinical Study Protocols The EMA has published the ICH M11 guideline, introducing a harmonised, structured and digital-ready template for clinical study protocols — a major step forward for global clinical research. 🔹...