FDA
The new article describes in detail the process of determining whether computer software used in the context of medical device manufacturing processes should be subject to validation. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
Asia
The article describes in detail the way the changes to medical devices are divided into categories and also highlights the key points to be considered in this respect. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere...
FDA
The new article describes in detail the aspects related to smart regulation and global harmonization for all the procedures and processes related to placing medical devices on the market. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
Asia
The article provides a brief overview of Singapore’s regulatory requirements in the sphere of change notification for medical devices. Table of Contents The Health Services Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has...
FDA
The present article provides additional details regarding specific aspects related to the policy for monkeypox tests, including the ones related to validation, serology tests, and also the availability of EUA templates. Table of Contents The Food and Drug...
