AI Program Can Predict Premature Death

USA – FDA : Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)...

Artificial intelligence (AI) and machine learning (ML) technologies have the potential to transform health care by deriving new and important insights from the vast...

International – Intellectual Property at the Intersection of Medical Devices and Artificial Intelligence

A medical device generally can be described as any device intended to be used for medical purposes, such as to benefit patients by (a) helping healthcare providers diagnose and...
HAS - Webinaire sur l'évaluation des dispositifs médicaux : visionnez le replay

France – IQSS 2020 – ETE ORTHO : Événements thrombo-emboliques après pose de prothèse...

Cet indicateur de résultat en chirurgie orthopédique mesurant les « Évènements thrombo-emboliques après pose de prothèse totale de hanche -hors fracture- ou de genou...
TGA Creates Advertising Guidance for Providers of Cell and Tissue Products

Australia – Regulation of software based medical devices : Update

The Governor-General in Council has made regulations which delay the commencement of a number of medical device reforms in Australia. This delay reflects the...

Canada – Guidance on summary reports and issue-related analyses for medical devices: Overview

This guidance document was prepared to help medical device manufacturers understand and comply with sections 25, 39 and 61.4 to 61.6 of the Medical Devices...
MHRA Offers Grace Period for Device Manufacturers Dealing With Withdrawn Notified Bodies

UK – Medicines and Medical Devices Bill: overarching documents

The impact assessment evaluates the measures in the Medicines and Medical Devices Bill and gives an overarching assessment of the impact they will have. The illustrative statutory...
TGA Creates Advertising Guidance for Providers of Cell and Tissue Products

Australia – Face masks and COVID-19

The Therapeutic Goods Administration (TGA) publishes information and resources about face masks for consumers, health professionals and industry. This page compiles all of our...

Europe – European Commission announces appointments to medical device, IVD Expert Panels

European Commissioners have published an official list of individuals appointed to serve on Expert Panels established under the Medical Devices Regulation (MDR) and In-vitro...
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs

USA – HHS pushes through last-minute policies impacting FDA

With just days remaining before the transition to a new administration, the Department of Health and Human Services (HHS) is pushing through policies that...

Europe – DM : La veille réglementaire et normative en un clin d’œil

Cher(e)s Client(e)s, Cher(e)s Collègues, Cher(e) Ami(e)s, L’année passée a été éprouvante pour beaucoup d’entre vous et peut-être douloureuse pour certains. C’est donc très chaleureusement et...

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