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...
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...
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...
FDA
The new article describes the particular way the least burdensome provisions should be applied to facilitate and streamline the regulatory processes associated with placing medical devices on the US market. Table of Contents The Food and Drug Administration (FDA or...
EU MDR/IVDR
The new article provides an overview of the medical device classification rules adopted in the European Union and highlights the key points associated thereto. Table of Contents The Borderline and Classification Working Group (BCWG), a subgroup of the Medical Device...
