FDA Revised Guidance on MR Safety: Image Artifact and Reporting Results
The article addresses the aspects related to possible image artifacts and the way they should be treated and also describes the approach to be applied when reporting results.
The article addresses the aspects related to possible image artifacts and the way they should be treated and also describes the approach to be applied when reporting results.
The article describes in detail the approach to be applied with respect to clinical evidence the parties responsible for medical devices are expected to provide when applying for marketing approval. Table of Contents The Health Sciences Authority (HSA), Singapore’s...
The article highlights the aspects related to the regulatory status of such categories as “medical device group”, “medical device group family” and “medical device system”. Table of Contents Health Canada, the Canadian regulating authority in the sphere of healthcare...
The Chinese Food and Drug Administration (CFDA) has issued a new “Medical Equipment Generic Naming Guide,” which will be implemented on April 1, 2016. This is the first regulatory document for ‘naming’ generic medical devices. The CFDA believes...
With emerging markets projected to account for 30% of global pharma market development, it’s important to note why having local consultants in those markets is vital. If not local, consultants are much more expensive. If a US consultant were hired for a project...