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…
Computer System Validation
Introduction Computer System Validation (CSV) is an extremely important subject for Quality Management System of highly regulated companies; software .…
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…
New ISO 14155:2020 Clinical Investigation for Medical Devices
Very recently, ISO published a new version of ISO 14155:2020 – Clinical investigation of medical devices for human subjects —…
ISO 15223-1:2021 : New Symbols for Medical Devices
ISO 15223-1:2021 new symbols for medical devices In this paragraph, we will talk about the update of ISO 15223-1 that…
What is ISO 13485 quality management system
Insights into the ISO 13485 certification process for Quality Management System. ISO 13485 certification is the process to certify that…
ISO 13485 and the FDA : The Future of Quality Management Systems
ISO 13485 and FDA: Harmonization with FDA QSR and insights on next version of ISO 13485 In this paragraph we…
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…
TGA’s Approach for Regulation of Direct to Consumer Digital Medical Devices
Introduction: Digital Medical Devices Regulation Direct to consumer (DTC) digital medical devices pose different challenges from regulation point of view;…
Cybersecurity Requirements for Medical Devices and EU MDR 2017/745
In the last decade, the role of cybersecurity substantially increased in the medical device sector; new guidelines to define cybersecurity…
