Corrective and Preventive Actions (CAPA)
There is no doubt that CAPA (Corrective and Preventive Actions) is one of the most important process of any Quality…
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…
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…
FDA Guideline on General Wellness Devices
The regulation of General Wellness Devices In recent years, there was a big increase in the distribution of general wellness…