IMDRF Offers Three Final Clinical Guidelines

International – IMDRF publishes new procedures on membership, governance

The International Medical Device Regulators Forum (IMDRF) recently updated its procedures for membership and for developing and managing technical guidelines. The 40-page Standard Operating Procedures...

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...
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...
Drugmakers Make Significant Headway in Track-and-Trace Compliance

International – E-labeling and digital transformation in healthcare

This article examines the regulations for electronic labeling (e-labeling) for prescription drugs and medical devices in Japan, Brazil, Singapore, the EU and US, Canada,...

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 guidances address cybersecurity, personalized devices and surveillance

The International Medical Device Regulators Forum (IMDRF) released four final guidances this week that address cybersecurity best practices, verification and validation for personalized medical...
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...
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,...

International – Enfin une norme internationale sur le dosage des EEB spécifique aux DM...

La série de normes ISO 11737, qui décrit les méthodes microbiologiques associées à la stérilisation des produits de santé, se déclinera dorénavant en trois...

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...

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