The FDA released their updated guidance on Cybersecurity in medical devices: Quality System Considerations and content for Premarket submissions at the end of June in 2025. In this guidance the FDA ...

Have you ever faced the daunting task of identifying and prioritizing risks in a project, only to feel overwhelmed by the sheer complexity of it all? Whether you’re managing a multi-million-dollar ...

This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method. According to the modern ...

For detailed information on the steps and considerations discussed below, see Data Security Risk Assessments and Reporting (US) on Practical Law. a written information security program (WISP) that ...