Clinical and Performance evidence requirements in the future EU IVD Regulation
Evolution of ISO 13485:2016 and ISO 9001:2015 standards
Nanomaterials in cosmetics: emerging needs in terms of characterization
Optimization of cosmetic packaging : Interactions between container and content
Advantages and challenges of MDSAP program and how to organize the transition to the CMDCAS Canadian program ?
CE Marking : Dealing with changes in medical devices in the framework of CE type and design examination
Upcoming revisions of EU regulations & the reclassification of In Vitro Diagnostics
Changes in certification standards ISO 9001:2015 and ISO 14001:2015
Reclassification of Medical Devices, upcoming revisions of EU regulations
Recent EU Medical Device Regulatory Evolutions: Moving Forward
Directive on Radio Equipment and Telecommunications Terminal Equipment (R&TTE): do your connected medical devices meet the requirements?
Medical Devices Containing Ancillary Medicinal Substances
The IVD Directive and borderline products
Medical devices intended for home use: what are the requirements of EN 60601-1-11 ?
Russia Medical Device Market Access, ISO 13485, and CE Marking for Medical Device Manufacturers
Sampling Medical Devices for Testing during Unannounced Audit
CE Marking and the Roles of Notified Bodies
How does ISO 27001 address the challenge of information security ?
Nanoparticles and Medical Devices: How to meet the regulation on the characterisation of materials ?
Mexico Medical Device Market Access and ISO 13485 certificat
How to change notified bodies (NB) for LNE/G-MED ?
Stand-alone software classification & regulation in Europe
Medical devices: exporting to the Brazilian and Mexican markets
MRI safety and compatibility of medical devices
