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...
Asia
The first article provides an overview of the general provisions of a new draft regulation on clinical trials for medical devices. Table of Contents The Turkish regulating authority has published a draft regulation on clinical trials for medical devices....
Asia
The Health Sciences Authority (HSA), Singapore’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to the classification of general medical devices. The document describes in detail the applicable classification rules...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to surgical staplers and staples. In particular, the document is intended to provide additional...
Australia and Oceania
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to incident reporting for medical devices. The document describes in detail the procedures to be followed...
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