We are excited to announce that RegDesk, the innovative Regulatory Information Management (RIM) platform, has been recognized as a Representative Vendor in the Gartner® Market Guide for Life Sciences Regulatory Information Management. Read the complimentary Market Guide for RIM Solutions report to learn more!
Globalization and the rapid advance of new technologies have presented a major challenge to regulators worldwide. Highly complex regulatory developments and the globalized production chain have advanced much faster than the availability of financial and human resources in most regulatory authorities.
The article provides an overview of the regulatory requirements for software as a medical device in Brazil. The Brazilian regulating authority in the sphere of medical devices (ANVISA), has published a questions and answers document dedicated to the regulatory...
The article provides an overview of the current regulatory framework for the re-registration of medical devices in Malaysia and describes in detail the most important aspects to be considered when submitting a respective application. The Medical Device Authority...
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has developed a guidance document dedicated to Pre-Requests for Designation (Pre-RFD). The document describes the approach to be applied by...
RegDesk is recognized as a Regulatory Intelligence Representative Vendor! Learn more by reading the 2024 Gartner® Market Guide for Regulatory Intelligence Solutions.
Medical Devices
