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...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the principles of software validation. The scope of the document covers, inter alia, the aspects...
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 the Global Unique Device Identification Database (GUDID). The document highlights the most important...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the Global Unique Device Identification Database (GUDID). The document is intended to provide...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the reporting of computational modeling studies in medical device submissions. The latest version of...
RegDesk is recognized as a Regulatory Intelligence Representative Vendor! Learn more by reading the 2024 Gartner® Market Guide for Regulatory Intelligence Solutions.
Get the report
