Pharmacopée Européenne : consultation publique sur la monographie « Préparations parentérales (0520) » et sur un nouveau chapitre informatif relatif à l’essai des particules visibles (5.17.2)

Europe – Pharmacopée Européenne : consultation publique sur la monographie « Préparations parentérales (0520)...

La Commission européenne de Pharmacopée a lancé une consultation auprès des parties intéressées sur deux textes majeurs portant sur le contrôle des produits pharmaceutiques...
Évaluation des technologies de santé à la HAS : place de la qualité de vie

France – Évaluation des technologies de santé à la HAS : place de la...

Un document de synthèse soulignant l’importance de disposer de données de qualité de vie dans les dossiers d’inscription des produits de santé a été...
Manufacturers of Thermal Therapy Devices Look to Mitigate Risk of Tissue Overheating

USA – Manufacturers of Thermal Therapy Devices Look to Mitigate Risk of Tissue Overheating

Medtronic and Monteris Medical are suggesting procedural techniques to reduce unintended thermal damage linked to their magnetic resonance-guided laser interstitial thermal therapy devices, the...
Hairy Coating Keeps Nanoparticles Safe from Immune System, Liver

USA – Hairy Coating Keeps Nanoparticles Safe from Immune System, Liver

Nanoparticles are seemingly a great way to treat tumors, but they’re so rapidly washed out by the bloodstream that few of the nanoparticles actually...
Chinese Regulators Revamp Innovative Medical Device Review Process

China – Chinese Regulators Revamp Innovative Medical Device Review Process

EMERGO SUMMARY OF KEY POINTS: The Chinese National Medical Products Administration (NMPA) has published revised requirements for its innovative medical device review program. NMPA...
UL Wades into Cybersecurity of Connected Medical Devices

USA – UL Wades into Cybersecurity of Connected Medical Devices

Safety science firm UL is honing in on the cybersecurity of connected medical devices, suggesting a two-pronged approach that spans across the total product...
US FDA Updates UDI Policy for Direct Marking of Medical Devices

USA – US FDA Updates UDI Policy for Direct Marking of Medical Devices

EMERGO SUMMARY OF KEY POINTS: US FDA has revised UDI direct marking requirements and deadlines for some non-sterile, Class I and unclassified medical devices. ...
MDSAP Consortium Sparks Debate Over Upcoming Revisions to ISO 13485:2016

International – MDSAP Consortium Sparks Debate Over Upcoming Revisions to ISO 13485:2016

In a letter to the ISO 13485 working group, the Medical Device Single Audit Program (MDSAP) Regulatory Authority Council (RAC) raised concerns over a...
MDR and IVDR Implementation: Update from the European Commission

Europe – MDR and IVDR Implementation: Update from the European Commission

MDR and IVDR implementations still on track as planned. The first Notified Bodies to be designated may be announced by the end of...
Global spinal fusion devices market poised for growth

International – Global spinal fusion devices market poised for growth

The global spinal fusion devices market is predicted to increase at a 3 percent compound annual growth rate through 2024, according to a Research and...

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