FDA
The first article provides an overview of the guidance document dedicated to the human factors and the way they should be considered when developing user interfaces for medical devices. Table of Contents The Food and Drug Administration (FDA or the...
FDA
The present article covers the matters related to the raw materials used for additive manufacturing, the impact of post-processing, and the validation of manufacturing processes. Table of Contents The Food and Drug Administration (FDA or the Agency), the...
FDA
The article provides an overview of the most important aspects to be considered for the impact the software could cause on the additive manufacturing process. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices, has published a guidance document dedicated to the applicable classification rules. The document is intended to provide medical device...
Europe
Swissmedic, the Swiss agency for therapeutic products, announced the implementation of a new technical standard to be used when submitting a marketing authorization application for a medicinal product. The present document constitutes an improved version of the...
