Sep 25 - 2:21
The FDA, the regulating authority in the sphere of medical device circulation of the United States, issued guidance providing additional information on new pilot conformity assessment procedures. ASCA: key points The...
Sep 6 - 3:52
What Is It? ISO 13485 is a quality management system that is used internationally. It controls safety in work environments, risk management, and design, and creates requirements for inspections, documents, procedures,...
Jul 17 - 4:36
International Medical Device Regulators Forum, a voluntary group of medical device regulators, emphasizes the importance of the terminology issue and submits a proposal to amend the existing system. Focus on...
