FDA Transitions to QMSR: Immediate Actions for Manufacturers
Effective Monday, February 2, 2026, the FDA officially transitioned to the Quality Management System Regulation…
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EU MDR
EU IVDR
US Agent
General
UK Responsible Person
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Australian TGA Sponsor
QA Consulting
Swiss Authorized Representative
Global Medical Device Classification Frameworks and Regulations
Medical device classification is the first major step in the regulatory process, whether you’re aiming to sell in the United…
Ensuring ISO 13485 QMS Compliance
Organizations claiming compliance with ISO 13485 or possessing…
What is MDSAP and How to Prepare for Your MDSAP Audit
The Medical Device Single Audit Program (MDSAP) is a framework that streamlines the quality system audit process for device…
QSR vs. QMSR: FDA’s New Quality System Requirements
On February 2, 2024, US FDA published the final rule harmonizing its quality system requirements to…
Standardizing Adverse Event Reporting: IMDRF Terminology
Despite having been published over three years ago, many manufacturers marketing their devices in IMDRF within the…
The Role of Regulatory Affairs in Product Development
In the complex and highly regulated world of medical…
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