NEWS & Events!

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On January 31, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align closely with the international standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world. The revised Part 820, now known as the Quality Management System Regulation (QMSR), will be enforced by the FDA starting on February 2nd, 2026.

New Regulations!

Therapeutic Goods Administration (TGA) have released a preview of the new Procedure for Recalls, Product Alerts and Product Corrections (PRAC) which will take effect in early March 2025. 

ISO 11137-1:2025 outlines requirements for developing, validating, and controlling sterilization processes for medical devices has been released in April 2025.

The latest update introduces changes such as expanded normative references, increased energy limits for electron beam and X-ray sterilization, and more flexible dose audit schedules., be sure to showcase a premium service. The new regulations will provide guidelines to ensure medical device market clearance.

FDA QMSR Demystified: What You Need to Know Before 2026

Certification Success: Planning, Training & Global Body Selection

Building Audit-Ready Systems: Internal & Supplier Oversight