Medical Devices
In today’s rapidly evolving healthcare landscape, medical device manufacturers face the dual challenge of driving innovation while ensuring regulatory compliance.
FDA
The new article provides a detailed overview of certain specific regulatory aspects associated with x-ray devices intended to be marketed and used in the US.
FDA
The new article clarifies the requirements pertaining to the date of manufacture and also highlights the measurement-related matters.
FDA
The article highlights the key points related to the radiation control legal framework.
FDA
The article highlights the key points associated with the regulatory status of dental ceramics, as well as the requirements they should comply with.
Medical Devices
The European Union Medical Device Regulation (EU MDR) significantly reshaped the landscape for medical device manufacturers, introducing stringent regulatory requirements aimed at enhancing patient safety and device efficacy. Enforced since May 2021, the MDR replaced the older Medical Device Directive (MDD), demanding greater transparency and accountability from manufacturers operating within the EU market.
