Design History File (DHF) for Medical Devices: Introduction This posts wants to provide an overview of the process of preparation of the design history file (DHF) for medical devices according to

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