MDCG 2020-16 Rev.3: IVDR Classification Rules
IVD news July 9, 2024MDCG 2020-16 is a key document outlining the classification rules for in vitro diagnostic medical devices (IVDs) under the EU... read more
Why Choose an ISO 14155-Compliant MedTech CRO?
MEDTECH news December 3, 2023Selecting an ISO 14155-compliant MedTech CRO under EU MDR ensures enhanced data reliability and patient safety. This compliance is key... read more
Understanding the MDCG 2023-4 Guidance on Medical Device Software and Hardware Combinations
MEDTECH news October 20, 2023The world of medical device regulation is constantly evolving, with regulatory bodies introducing new guidances to keep up with the... read more
IVD Software Development: How to Bring IVD Software to Market in 8 Steps
IVD news April 4, 2023The healthcare industry is undergoing a rapid transformation spurred by the advent of advanced medical diagnostic technology. IVD software development... read more
WHO Guidance for Digital Health Nov 2022: Monitoring the implementation of digital health
SOFTWARE news November 23, 2022In recent years, there has been a dramatic increase in the use of digital health tools health in order to... read more
Understanding MDCG 2020-10 Rev 1: Safety Reporting in Medical Device
MEDTECH news November 21, 2022In light of the forthcoming Medical Device Regulation (MDR) and the delay in the complete functionality of the electronic system... read more
MedTech Europe urges parliamentarians assess the challenges of the EU MDR 2017/745
MEDTECH news November 9, 2022Assisting with the EU Medical Devices Regulation Europe faces imminent shortages of medical equipment needed by hospitals and clinicians to... read more
Position paper on cyber security
MEDTECH news October 13, 2022This paper has been prepared thanks to the task force and endorsed during the general assembly meeting. It is a... read more
New Team NB Position Paper | Best Practice for Submission of EU MDR Technical Documentation
MEDTECH news October 7, 2022To create a consistent approach to the requirements of technical documentation submissions from manufacturers, members of Team NB reviewed the... read more
Draft of Principles and Practices for Software Bill of Material for Medical Device Cybersecurity
SOFTWARE news August 23, 2022Due to the usage of shared software components, #cybersecurityvulnerabilities may affect a wide variety of apparently secure unconnected products from... read more
IMDRF Machine Learning-enabled Medical Devices: Key Terms and Definitions
SOFTWARE news June 3, 2022The main purpose of this new guidance t is to create uniform expectations and understanding for Machine Learning-enabled Medical Devices... read more
AI and the Software as a Medical Device
SOFTWARE news 27 November, 2021Deep learning techniques using neural networks are used in medical devices to fulfill human capabilities in a variety of roles, such as: Disease prediction, detection, classification, and analysis.
