Design History File (DHF): An Overview
Design History File (DHF) for Medical Devices: Introduction This posts wants to provide an overview of the process of preparation…
Computer System Validation
Introduction Computer System Validation (CSV) is an extremely important subject for Quality Management System of highly regulated companies; software .…
FDA meets Digital Health Devices: the Pre-Cert Program
FDA Digital Health Devices Regulation – Pre-Cert Program FDA has launched the so-called Software Pre-Cert Program. The goal is to…