AI Act and Medical Devices: An Overview
Over the past year, the discourse around Artificial Intelligence (AI) and its potential dangers has permeated public dialogue, emerging as…
Business Continuity Plan: Strategies for Implementation
As the digital era continues to expand, information security stands as a cornerstone of modern business strategy and having a…
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…
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
Introduction: Cybersecurity Requirements and EU MDR 2017/745 In the last decade, the role of cybersecurity substantially increased in the medical…
Digital Health Devices : Challenges for Regulatory Compliance
Digital Health Devices raised a lot of attention to the MedDevice community for the challenges that need to be addressed…
Artificial Intelligence and Machine Learning as Medical Device Software
Artificial Intelligence for Medical Device: new challenges for regulatory compliance.
