FDA The new article addresses the aspects related to the manufacturing information the authority expects to be included in the submissions. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
Asia The article highlights the most important aspects associated with the declaration of conformity to be issued by a party responsible for a medical device to demonstrate compliance with the applicable safety and performance requirements. ...
FDA The article provides an overview of the Safer Technologies Program, a special regulatory framework for medical devices introduced in the US. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
Asia The new article provides additional details regarding the specific aspects covered by the scope of the new regulation on clinical trials for medical devices. Table of Contents The new regulation related to clinical trials for medical devices has been...
FDA The new article describes in detail the content of the submission in terms of quality system information and also highlights the aspects related to the design control information. Table of Contents The Food and Drug Administration...
Asia The new article describes in detail the approach to be applied when analyzing the data deriving from clinical investigations. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of...
