News

The European Commission has published the new version of the Manufacturer Incident Report (MIR) – Form 7.3.1. Its use will be mandatory for all…

The U.S. Food and Drug Administration (FDA) has released a new draft guidance [TR1] providing recommendations for non-clinical and clinical…

We are pleased to announce that NSF will be participating in this year's 6TH ANNUAL BTEL SUMMIT & EXHIBITION from March 26th to 27th. Our expert, Dr.…

The Commission Notice C/2025/214, published in January 2025, provides guidance on the consistent application of the provisions on the removal and…

The new Medical Devices Amendment Regulations 2024, which update the UK Medical Devices Regulations 2002, affects all medical devices in Great…

It’s that time of the year again. The medical device registrants and filers must prepare and submit their Annual Quality Management System…

The draft of the second edition of the IEC 62304 will introduce key changes focused on simplifying software classification and expanding the scope of…

The European Commission has launched a public consultation on the EU's legislation concerning medical devices and in vitro diagnostic medical devices.…

In 2025, Notified Bodies will be required by the Federal Ministry of Health to conduct unannounced audits at manufacturers of medical devices. As part…