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...
FDA
The article provides a general overview of the regulatory requirements, and also briefly describes the key concepts. Table of Contents The United States Food and Drug Administration has released a guidance document about Off-The-Shelf (OTS) software used in...
Asia
The article provides an overview of the existing regulatory framework for submissions related to healthcare products. Table of Contents The Health Services Authority (HSA), Singapore’s regulating authority in the sphere of healthcare products, has published a guidance...
FDA
The new article describes in detail the aspects related to the regulatory status of medical device development tools in comparison to medical devices. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
FDA
The new article provides an overview of the main points highlighted by the authority in terms of the applicable regulatory requirements and also outlines the aspects to be taken into consideration when following the applicable rules. Table of Contents The Food and...
Europe
The article describes the approach to be applied when determining the regulatory status of a borderline product that could be subject to regulation under the medical devices framework, and also pays special attention to the applicable risk-based classification. Table...
