LNE-GMED

France – Le LNE filialise son activité GMed de certification médicale

Depuis cinq ans, la certification des dispositifs médicaux connaît un véritable bouleversement. La croissance des exigences normatives et règlementaires a généré une croissance importante...
Bipartisan Bill would allow Drug Imports from Canada

Canada – Health Canada Developing MDL Policies for 3D-Printed Medical Devices

EMERGO SUMMARY OF KEY POINTS: Health Canada to publish new guidance on MDL requirements for 3D-printed medical devices. The Draft guidance will cover Class...
New Virtual Surgical Simulator Debuts in Germany

Germany – New Virtual Surgical Simulator Debuts in Germany

Researchers presented the latest innovation in surgical training at this year’s MEDICA 2018 conference in Düsseldorf, Germany — the HandsOn.surgery trainer. The new prototype...
Déployer des dispositifs médicaux IoT en toute confiance

Europe – Déployer des dispositifs médicaux IoT en toute confiance

Alors que l’année 2020 approche, le nombre d’appareils connectés progresse en capacité, augmente en nombre et révolutionne toutes les formes de communication. Ces dispositifs...
FDA Promises Flexibility for Stem Cell Trials

USA – FDA Warns Against Using Implanted Pumps With Unapproved Drugs

The US Food and Drug Administration (FDA) on Wednesday warned physicians against using implantable pumps to deliver pain medications directly into patients’ spinal fluid...
Wearable device studied for detection of pediatric anxiety, depression

USA – Wearable device studied for detection of pediatric anxiety, depression

When Ellen McGinnis started her career as a psychologist several years ago, she realized just how hard it can be to spot anxiety and...
Australian medical device regulators preparing Brexit contingency plans

Australia – Australian medical device regulators preparing Brexit contingency plans

The Australian TGA has drawn up plans to blunt the impact of Brexit on the country’s medical device market. TGA will continue recognizing...
Philips Unveils Augmented Infant Resuscitator for Safe Rescue of Asphyxiated Newborns

USA – Philips Unveils Augmented Infant Resuscitator for Safe Rescue of Asphyxiated Newborns

A collaboration between Philips, and researchers at Massachusetts General Hospital, Mbarara University of Science and Technology in Uganda, and MIT, has developed a device that helps...
EU MDR/IVDR: European Commissioner Looks to Quash Transition Concerns

Europe – EU MDR/IVDR: European Commissioner Looks to Quash Transition Concerns

The road to the new European medical device and in vitro diagnostic regulations (MDR/IVDR) has raised many concerns, but a European Commissioner recently attempted to ease...
Cybersécurité : un sujet à prendre au sérieux pour les dispositifs médicaux

International – Cybersécurité : un sujet à prendre au sérieux pour les dispositifs médicaux

Les dispositifs médicaux sont passés d’équipements autrefois isolés à des équipements connectés en réseau avec communication bidirectionnelle, accès à distance et connectivité sans fil....

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