News

New vigilance system guidelines for CE-marked medical devices MDCG 2024-1

In January 2024, a new MDCG 2024-1 Device Specific Vigilance Guidance (DSVG) Template was created to standardize the way medical incidents, serious in...

Katarzyna Romaniszyn Head of Regulatory and Quality Management Department

The US FDA published its final rule aligning U.S. quality regulations (QMSR) to international standards (ISO 13485)

The US FDA has released the awaited final decree on Quality Management System Regulation (QMSR), bringing its stipulations into alignment with the wid...

Katarzyna Wesołowska Board Member