International – Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles

In 2021, the U.S. Food and Drug Administration (FDA), Health Canada, and the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) jointly identified 10...

International – Des valves cardiaques imprimées en 3D

Une équipe internationale germano-australienne a mis au point des valves cardiaques artificielles imprimées en 3D, conçues pour permettre aux propres cellules d’un patient de...
IMDRF Offers Three Final Clinical Guidelines

International – IMDRF guidance updates thinking on personalized medical devices

The International Medical Device Regulators Forum (IMDRF) says personalized medical devices (PMD) come in three varieties that require different regulatory approaches. As certain technologies...
ISO 14971 :2019 - GAP-ANALYSIS résumé versus l’ancienne version ISO EN FR 14971 : 2013.

International – Révision de la norme ISO 10993-17 : quelles évolutions ?

L’évaluation biologique des dispositifs médicaux est réalisée selon les normes de la série ISO 10993 et repose sur un processus de gestion des risques....
IMDRF Offers Three Final Clinical Guidelines

International – IMDRF guidance aims to harmonize, streamline review reports

The International Medical Device Regulators Forum (IMDRF) recently published guidance intended to streamline regulatory reporting requirements across jurisdictions. The document lays out expectations not...

International – Diabète : un pansement intelligent pour soigner et cicatriser les plaies chroniques

Les plaies chroniques dites « non cicatrisantes » concernent des dizaines de millions de personnes dans le monde. Ainsi, de 15 % à 25 % des patients diabétiques...
IMDRF Offers Three Final Clinical Guidelines

International – IMDRF publishes updated guides covering governance activities and membership

The International Medical Device Regulators Forum (IMDRF) recently posted a series of updated guidelines on the group’s standard operating procedures (SOP), criteria for joining,...

Israel – New study use musical tests for early detection of cognitive decline

“Our method enables routine monitoring and early detection of cognitive decline in order to provide treatment and prevent rapid, severe deterioration,” said the researchers...
Saudi FDA moves to single electronic platform for medical device registrations

Saudi Arabia – Saudi FDA postpones Unique Device Identification compliance deadlines

The Saudi Food and Drug Authority (SFDA), Saudi Arabia’s medical device market regulator, has once again announced the postponement of its Unique Device Identification (UDI) requirements...
IMDRF Offers Three Final Clinical Guidelines

International – IMDRF proposes legacy device cybersecurity guidance after stakeholder feedback

Communication between manufacturers and healthcare providers is key to ensuring patients with legacy medical devices are kept safe according to proposed cybersecurity guidance from...

NOS PROCHAINES FORMATIONS