International – RF Quarterly, September 2024: Artificial intelligence in medical devices
Welcome to the September issue of RF Quarterly, which includes articles examining artificial intelligence (AI) in medical devices, focusing on the global regulatory landscape, contact-free AI...
India – Central Drugs Standard Control Organization (CDSCO) under Ministry of Health & Family...
The Ministry of Health and Family Welfare has introduced comprehensive regulations for medical devices aimed at aligning the country's regulatory framework with globally accepted...
International – The global regulatory landscape for AI/ML-enabled medical devices
Digital health has revolutionized the healthcare sector. Artificial intelligence (AI) and machine learning (ML) have gained widespread recognition because of their promising benefits in...
International – Artificial intelligence in medical devices
Welcome to the September issue of RF Quarterly, which includes articles examining artificial intelligence (AI) in medical devices, focusing on the global regulatory landscape, contact-free AI...
International – IMDRF Document Implementation Report – Final document
This report (30 August 2024) provides details on the status of various medical device regulations, as self-identified by IMDRF members. It covers documents on...
International – ISO/DIS 10993-1(en) Biological evaluation of medical devices — Part 1: Requirements and...
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried...
International – Lancement de la plateforme MeDevIS pour améliorer l’accès aux technologies et dispositifs...
L’Organisation mondiale de la Santé (OMS) annonce le lancement en ligne du Système d’information sur les dispositifs médicaux (MeDevIS), la première plateforme mondiale d’échange...
International – ISO/DIS 14155 will replace ISO 14155:2020
This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the...
International – 1SO 10933-1:2018 will be replaced by ISO/DIS 10993-1
Biological evaluation of medical devices
Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
This document specifies:
—...
International – IMDRF publishes AI/ML guiding principles echoing US, UK, Canadian regulators
The International Medical Device Regulators Forum (IMDRF) has published guiding principles for artificial intelligence/good machine learning (AI/ML) practices in medical device development that are...
