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?

Christine QUINTON Technical File Evaluation Manager - LNE/G-MED

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

Christine QUINTON Technical File Evaluation Manager - LNE/G-MED

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

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

Christine QUINTON Technical File Evaluation Manager - LNE/G-MED

Upcoming revisions of EU regulations & the reclassification of In Vitro Diagnostics

Sheena BOND Certification Project Manager - Lead Auditor - LNE/G-MED NA

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

Sheena BOND Certification Project Manager - Lead Auditor - LNE/G-MED NA

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

Sarah STEC Legal and Regulatory Director - LNE/G-MED NA

INMETRO Certification

Sarah STEC Legal and Regulatory Director - LNE/G-MED NA

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 ?

Christine QUINTON Technical File Evaluation Manager - 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