Biocompatibility evaluation according to ISO 10993-1 is one of the most important validation activities for medical device. It is an important process during the design

The role of post-market surveillance for medical device manufacturers became more and more important. In this post we give an overview to ISO 20416:2020, a

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)

Introduction Computer System Validation is an extremely important subject for Quality Management System of highly regulated companies. In fact, every company focusing on medical device or

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

Very recently, ISO published a new version of ISO 14155:2020 - Clinical investigation of medical devices for human subjects — Good clinical practice. The

ISO 15223-1:2020 new symbols for medical devices In this paragraph, we will talk about the update of ISO 15223-1 that will introduce new symbols to add

Insights into the ISO 13485 certification process for Quality Management System. ISO 13485 certification is the process to certify that a quality management system

ISO 13485 FDA ISO 13485 and FDA: Harmonization with FDA QSR and insights on next version of ISO 13485 In this paragraph we want to discuss about

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