As the digital era continues to expand, information security stands as a cornerstone of modern business strategy and having a suitable Business Continuity Plan in place is a must. For

Introduction Computer System Validation (CSV) is an extremely important subject for Quality Management System of highly regulated companies; software . In fact, every company focusing on medical device or pharmaceutical business

FDA Digital Health Devices Regulation - Pre-Cert Program FDA has launched the so-called Software Pre-Cert Program. The goal is to provide a specific regulatory pathway for market access which is more

The regulation of General Wellness Devices In recent years, there was a big increase in the distribution of general wellness devices. In fact, there was the need of a guideline

Introduction: Digital Medical Devices Regulation Direct to consumer (DTC) digital medical devices pose different challenges from regulation point of view; in this post I want to speak about the approach