All posts by : Andrea Valoti

An important update has been introduced for medical device manufacturers and regulatory professionals with the release of an amendment to ISO 15223-1:2021, the international standard for labeling medical devices.

The Supreme Court has confirmed the conviction of the Plant Manager of Albea Cosmetics Italy Srl, A.A., for serious personal injury following an accident at work.

These guidelines, introduced under the Good Practice Guide for Qualification and Validation, aim to revolutionize pharmaceutical processes by enhancing efficiency and ensuring compliance with evolving industry standards.

The “Terminologies for Categorized Adverse Event Reporting” document introduces significant updates for medical device manufacturers, regulatory bodies, and healthcare professionals.

TGA in Australia has rolled out the Unique Device Identification (UDI) system, a groundbreaking initiative aimed at improving the traceability and safety of medical devices.

MHRA has published updated guidance on medical device registration, specific to the UK market.

The European Union Agency for Cybersecurity (ENISA) has released its highly anticipated 2024 Cybersecurity Maturity Assessment for sectors under the NIS2 Directive.

This consultation specifically addresses the use of mercury in “other discharge lamps for special purposes.”

The Italian Supreme Court has issued an important clarification regarding the criteria for identifying a “de facto” employer in workplace health and safety criminal matters.