In this article, we want to give you a deep dive into the requirements associated to the Design and Development Plan. As you know, the Design Process for medical devices

Introduction to Verification vs Validation Design verification and validation are critical components of the design process when developing a medical device. It is vital to have a clear understanding of

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