FDA
The article provides a general overview of the applicable regulatory requirements and highlights the key points associated thereto.
MDCG
The document provides an overview of the EtO regulatory status and highlights the key points to be taken into consideration by the medical device manufacturers utilizing it in their processes.
MDCG
The final article of the cycle highlights the key points related to certain specific product categories, outlining the most important aspects to be taken into consideration.
ANVISA
The article provides a brief overview of the regulatory requirements applicable to personalised medical devices intended to be marketed and used in Brazil.
EU
The article highlights the key points related to the regulatory status of in vitro diagnostic medical devices under the existing legal framework.
