What is Verification and Validation Design Verification and validation are essential concepts for the design process of a medical device and it is of fundamental importance to fully understand

ISO 62366 plays a fundamental role in the design process for medical device as it explains the requirements related to usability. Usability studies are an essential part of the design

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