Top 10 Medical Innovations for 2019

USA – Top 10 Medical Innovations for 2019

Alternate therapies for pain. The use of artificial intelligence in healthcare. Expanded window to treat stroke patients. These are some of the innovations that...
How One Digital Health Company is Outsmarting Diabetes

Israel – How One Digital Health Company is Outsmarting Diabetes

There’s no doubt it will take a lot to curve the growing number of diabetes cases worldwide. But in order to deal with such...
10 of the Most Influential Companies in the Cardiovascular Space

International – 10 of the Most Influential Companies in the Cardiovascular Space

The cardiovascular space has been among the most exciting in medtech in recent years. A special panel at MD&M East, "Unmet Needs Straight from...
Norway’s DNV GL Designated as 10th Notified Body Under MDRClinical Trials With Conditions

Europe – Norway’s DNV GL Designated as 10th Notified Body Under MDR

Norwegian notified body (NB) DNV GL Presafe AS on Thursday was added to the European Commission’s NANDO database as the 10th NB to be designated...
Japanese regulatory ministry publishes guidance on biocompatibility testing to updated standard

Japan – Japan PMD Act revisions include fast-track reviews for some medical devices and...

Significant revisions to Japanese regulations of medical devices, IVDs and other healthcare products have begun taking effect, with phased implementations of new and updated...

France – « Actualités 2021 sur les dispositifs médicaux » avec Jean-Claude GHISLAIN

Jean-Claude GHISLAIN sera interviewé par notre confrère Yves TILLET, Fondateur du Cabinet WHITE-TILLET (Groupe NEOVIX-BIOSCIENCES), expert du domaine des DM/Produits combinés et membre du...

USA – Update: Check first with FDA regarding their current availability to review a...

In recent years, the US Food and Drug Administration has strongly encouraged medical device manufacturers to submit human factors (HF) validation test protocols for...
FDA : New steps to strengthen the process of initiating voluntary recalls

USA – Zimmer Biomet Recalls 1,300 Bone Growth and Spinal Fusion Stimulators

A recall that Zimmer Biomet initiated in February has just been identified by FDA as a Class I recall, marking it the most serious...
Les changements avec le RDM : le livret explicatif et pédagogique du SNITEM (Mars 2020)

France – Nouveau livret du SNITEM : la Personne chargée de veiller au respect...

Nouveau livret du SNITEM : la Personne chargée de veiller au respect de la réglementation
Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

Europe – EC Selects Four UDI Issuing Entities

The European Commission (EC) last week revealed that GS1, the Health Industry Business Communications Council (HIBCC), ICCBA and Informationsstelle für Arzneispezialitäten (IFA GmbH) will...

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