Nov 3, 2023
EU
The article provides an overview of the provisions of a guidance document and highlights the key points to be taken into consideration by medical device manufacturers (software developers).
Read More
Oct 25, 2023
FDA
The new article highlights the aspects related to non-clinical testing considerations related to the devices covered by the scope of the guidance.
Read More
Sep 22, 2023
MHRA
The new article highlights aspects related to the in-house manufacture of in vitro diagnostic medical devices. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulating authority in the sphere of healthcare products,...
Read More
Sep 22, 2023
MHRA
The article provides a general overview of the regulatory requirements for in vitro diagnostic medical devices intended to be marketed and used in the United Kingdom. Table of Contents The Medicines and Healthcare products Regulatory Agency (MHRA), the UK...
Read More
Sep 22, 2023
FDA
The article provides a general overview of the Risk Assessment and Software testing for Off-The-Shelf Sftware as given by FDA. Table of Contents The United States Food and Drug Administration has released a guidance document about Off-The-Shelf (OTS) software...
Read More