Sep 13 - 4:10
FDA’s Center for Devices and Radiological Health (CDRH) holds a meeting to discuss the risks and threats of cybersecurity in medical devices. They describe the unique challenges involved with security and how difficult...
Sep 12 - 6:04
The Food and Drugs Administration (FDA), the US authorized body who provides regulation and supervision in the sphere of medical products and devices, finalized a guidance on De Novo applications. De Novo Pathway De...
Sep 10 - 5:26
The US Food and Drug Administration (FDA) finalized guidance on the Humanitarian Device Exemption (HDE) program on Thursday, reflecting amendments made by the 21st Century Cures Act (Cures Act) and the FDA...
Sep 9 - 6:24
British medical products regulating authority, the MHRA, issued a special guidance describing the impact Brexit could have on medical device regulations. The guidance describes the consequences of Brexit to all parties...
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,...
