Bluetooth-enabled implant may be future of medication management

USA – Bluetooth-enabled implant may be future of medication management

A Bluetooth-enabled drug delivery technology could vastly improve chronic disease management in the future, according to a recent paper published in Lab on a Chip. Nanomedicine...
Cyber security for medical devices and IVDs

Australia – Cyber security for medical devices and IVDs

Cybersecurity is an important consideration for medical devices and IVD medical devices (IVDs). We have produced guidance specific to industry as well as guidance...
Breast implants and anaplastic large cell lymphoma

Australia – Breast implants and anaplastic large cell lymphoma

This update reflects the TGA's initial views following recent laboratory testing and statistical analysis. Breast implant sponsors have until 24 July to provide additional...
Updated Fundamentals of US Regulatory Affairs Book

USA – Updated Fundamentals of US Regulatory Affairs Book

RAPS has just published the updated, 11th edition of Fundamentals of US Regulatory Affairs, the most extensive regulatory affairs textbook available, covering US regulations for...
L’ANSM lance une consultation publique sur un projet de recommandations pour la cybersécurité des dispositifs médicaux

France – ANSM : L’ANSM lance une consultation publique sur un projet de recommandations...

C’est la première fois en Europe que des recommandations dans ce domaine sont élaborées et l’ANSM a partagé ses travaux avec la Commission européenne...
Chinese regulators preparing medical device UDI pilot

China – Chinese regulators preparing medical device UDI pilot

The National Medical Products Administration (NMPA), China’s medical device market regulator, has begun laying the groundwork for a Unique Device Identification (UDI) pilot program...
Le Plan Juncker soutient la recherche dans le traitement des maladies orphelines en France

Europe – European Commission clarifies medical device vigilance requirements

The European Commission has published new guidance clarifying manufacturers’ obligations under the Medical Device Vigilance System established by the Medical Devices Directive (MDD). The guidance augments issues...
State of flux: European Notified Body numbers decrease further ahead of MDR, IVDR

Europe – State of flux: European Notified Body numbers decrease further ahead of...

The European Notified Body (NB) landscape remains in uncertain territory as additional entities opt out of designation to the Medical Devices Regulation (MDR) and...
4 Key Usability Considerations For Biopharmaceutical Delivery Device Design

USA – 4 Key Usability Considerations For Biopharmaceutical Delivery Device Design

Often, the last thing on the minds of drug development teams working on a new generation of large-molecule biologics is the human factors engineering...
Will Medtech Rise to FDA's Sterilization Challenge?

USA – Will Medtech Rise to FDA’s Sterilization Challenge?

FDA issued two challenges Monday, both of which aim to address the environmental concerns surrounding the use of a gas called ethylene oxide to sterilize...

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