There is no doubt that CAPA (Corrective and Preventive Actions) is one of the most important process of any Quality Management System based on ISO 13485:2016. We have already been

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

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