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FDA’s CDRA Warns About Cybersecurity
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...
FDA Updated Guidance on De Novo Requests
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...
FDA Finalized Guidance on HDE Program
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...
MHRA Guidance about No-Deal Brexit
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...
Difference Between ISO 13485: 2012 and 2016
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,...