The European Commission’s proposal for new common specifications for certain high-risk in vitro diagnostic devices (IVDs) reflects an ongoing effort […]
The Medical Device Regulation (MDR) introduced by the European Union (EU) marks a significant overhaul in the regulation of medical
The aim of this document is to demystify the concept and purpose of a technical file as required under the
Entering the Australian market with a medical device requires a thorough understanding of the regulations set by the Therapeutic Goods
As we look into medical devices within the European Union, Medical Device Vigilance and incident reporting represent critical facets of
Understanding the complexities of regulatory compliance is essential for medical device manufacturers aiming to enter or maintain their presence in
On January 31, 2024, the FDA issued a significant final rule amending the Quality Management System Regulation (QMSR), which aligns
The shift towards the Medical Device Regulation (MDR) signifies a major transformation within the medical device sector in the European
Welcome to our guide on navigating Unique Device Identification (UDI) compliance in the medical device industry. As the healthcare sector
Welcome to our latest blog post where we will be looking into Own Brand Labelling (OBL) in the medical device
