AIaMD
The article provides a general overview of the regulatory framework applicable to certain innovative products intended to be marketed and used in the UK.
HSA
The new article highlights the aspects related to the general principles of clinical evaluation.
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).
CDRH
This article describes Software Based Medical Devices and their key regulatory considerations. Table of Contents Software is now a crucial component of every product as technology continues to develop all elements of health care. It is widely integrated into digital...
Australia and Oceania
The Therapeutic Goods Administration (TGA), a division of Australia’s Department of Health responsible for medical devices circulation, issues new guidance dedicated to the evidence requirements. The new guidance published by the TGA is intended to provide entities...
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