IMDRF Seeks Input on Regulatory Pathways for Personalized Medical Devices

International – IMDRF proposes update on postmarketing device studies

The International Medical Device Regulators Forum has issued a proposed update to its guidance on postmarket clinical follow-up (PMCF) studies for medical devices, with...

International – 2020 amendments to IEC62366 – implications for medical device usability engineering

Several amendments to the text of the international standard IEC 62366-1: Application of usability engineering to medical devices have been published in June 2020....

Russia – Russian Ministry of Health articulates role of SaMD in medical device regulation

Russia’s Ministry of Health (MoH) issued an order and two draft resolutions addressing the regulation of software as a medical device (SaMD). The changes...

International – Audit MDSAP : le retour d’expérience d’un expert en affaires règlementaires

Les fabricants de dispositifs médicaux évoluent aujourd’hui dans un environnement règlementaire dynamique, incertain et historiquement segmenté. Cependant, c’est bien dans une perspective d’harmonisation internationale...

International – Medical Device Innovation Consortium Releases Real-World Evidence Framework for In Vitro Diagnostics

The Medical Device Innovation Consortium (MDIC) has announced the release of its Real-World Evidence Framework for regulatory decision-making for in vitro diagnostics (IVDs). Created through...

International – Strategies to Prevent Component Shortages During a Crisis

COVID-19’s impact on manufacturing has created a number of business roadblocks, including order cancelations, large fluctuations in demand, supply chain issues, and reduced production...

International – EU OKs coronavirus test from Macrogen

South Korea’s Macrogen has received a CE mark for a new coronavirus test kit, Axen COVID-19 RT. The test confirms if a patient is infected...

International – 10 steps to conducting a use-related risk analysis as part of your...

Use-related risk analysis (URRA) is a cornerstone activity for a thorough human factors engineering (HFE) process that meets the expectations set forth by US...

International – Researchers develop prostate cancer blood test

A new blood test for prostate cancer is producing a 99% accuracy rating—precision that has never before been achieved for a blood test of...
ISO 14971 :2019 - GAP-ANALYSIS résumé versus l’ancienne version ISO EN FR 14971 : 2013.

International – ISO/TR 20416:2020 – Surveillance après mise sur le marché incombant aux fabricants

Le présent document fournit des recommandations relatives au processus de surveillance après mise sur le marché et est destiné à être utilisé par les...

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