The device master record is a design document specifically requested by the FDA Quality System Regulation, as per 21 CFR 820.181. If we follow the definition reported in the regulation:

The UDI (Unique Device Identification) is a system used to uniquely identify medical device sold in a specific country, for example in United States. FDA started the implementation of UDI

Although there are different ISO standards which define the requirements for labelling related to medical device, such us ISO 15223-1 and ISO 20417, FDA has also some specific requirements that

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

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. First of all there

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