CE marking of medical devices: Elements to be provided for the assessment of a technical file
Christine QUINTON Technical File Evaluation Manager - LNE/G-MED
Medical Device Usability : Highlights of European Regulations and the Latest Standards
Sara JAFARI, Ph.D. Medical Device Certification Project Manager / Active Medical Devices - LNE/G-MED
Post-market surveillance requirements under new European regulations
Florianne TORSET - BONFILLOU Director of Regulatory, Education and Quality / Lead Auditor - LNE/G-MED
Biocompatibility: How to demonstrate the control of the biological risk according to the NF EN ISO 10993-1 (2010) standard?
E-health technologies in Medical Devices: identification of the key development milestones and regulatory constraints
Christophe AMIEL Senior Director, Medical Devices & Combination Products @ Voisin Consulting Life Science
Medical devices clinical data evaluation : The new provisions of MEDDEV 2.7/1 revision 4
Embedded software in medical device: common regulatory and quality pitfalls
Mohamed ALSAADI Certification Project Manager - Lead Auditor - LNE/G-MED NA
Clinical and Performance evidence requirements in the future EU IVD Regulation
Julien SENAC Certification Project Manager - LNE/G-MED
Evolution of ISO 13485:2016 and ISO 9001:2015 standards
Florianne TORSET-BONFILLOU Technical Department Director - LNE/G-MED
Nanomaterials in cosmetics: emerging needs in terms of characterization
Georges FAVRE Nanomaterials Product manager - LNE
Optimization of cosmetic packaging : Interactions between container and content
Patrick SAUVEGRAIN R&D Coordinator - LNE
Advantages and challenges of MDSAP program and how to organize the transition to the CMDCAS Canadian program ?
Corinne DELORME Regulatory Affairs Global Manager - LNE
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
Sheena BOND Certification Project Manager - Lead Auditor - LNE/G-MED NA
Changes in certification standards ISO 9001:2015 and ISO 14001:2015
Stéphane GENEAU DE LAMARLIERE Certification project manager and SMQ lead auditor, LNE Cetification Division
Emmanuel REBUFFAT Certification project manager and LNE expert in transition matters regarding the ISO 14001 standard
Reclassification of Medical Devices, upcoming revisions of EU regulations
Anne LE ROUZO Sr Lead Auditor ISO 13485, ISO 9001, CMDR, MDD, AO regulations
Recent EU Medical Device Regulatory Evolutions: Moving Forward
Sarah STEC Legal and Regulatory Director - LNE/G-MED NA
Directive on Radio Equipment and Telecommunications Terminal Equipment (R&TTE): do your connected medical devices meet the requirements?
Christophe WEIDEN Project Manager at CETECOM Group - testing and certification of radio products.
Medical Devices Containing Ancillary Medicinal Substances
Sam SHAKIR Certification Project Manager - LNE/G-MED NA
The IVD Directive and borderline products
Medical devices intended for home use: what are the requirements of EN 60601-1-11 ?
Patrick SORREAUX Technical Manager - Electrical Safety of medical electrical devices, Testing department / LNE
Russia Medical Device Market Access, ISO 13485, and CE Marking for Medical Device Manufacturers
Alexey STEPANOV Regulatory and Quality Assurance Manager Russia and CIS / Sorin Group
Sampling Medical Devices for Testing during Unannounced Audit
Florianne TORSET-BONFILOU Technical Department Director, Lead Auditor - LNE/G-MED NA
CE Marking and the Roles of Notified Bodies
How does ISO 27001 address the challenge of information security ?
Dimitri DRUELLE Expert of the family of standards ISO 27000 / Gfi Informatique
INMETRO Certification
Nanoparticles and Medical Devices: How to meet the regulation on the characterisation of materials ?
Georges FAVRE R&D Programme Manager / LNE
Mexico Medical Device Market Access and ISO 13485 certificat
Sarah STEC Legal and Regulatory Director -LNE/G-MED NA
Miguel Angel TORRES TELLO - EmergoGroup Mexico
How to change notified bodies (NB) for LNE/G-MED ?
Stand-alone software classification & regulation in Europe
Franck MARTIN Senior QA RA Consultant and CEO of ExpeReg
Sarah STEC Legal and Regulatory Director, G-MED North America
Medical devices: exporting to the Brazilian and Mexican markets
Christiane BINET Europe Manager for Health sector companies
Stephan FONTANEL Founding Director at CroftHawk et Mandala Associés
MRI safety and compatibility of medical devices
Yannick PONVIANNE Healtis' CEO
HEALTIS A company that specialises in MRI Safety