Upcoming Trainings Register Today!
|Course Title||Trainer||Date & Location||Sign up here|
|The transition to ISO 13485:2016 & The fundamentals of the Medical Device Single Audit Program (MDSAP) for Medical Device Manufacturers||Florianne Torset- Bonfillou,
Director of Regulatory,
Education and Quality
|September 13-14th, 2017
Silver Spring, MD
|Program & Registration|
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RAPS 2017 - Save the date!
LNE/G-MED NA will participate to RAPS 2017 Regulatory Convergence, at the Gaylord National Resort & Convention Center at National Harbor, MD. The Regulatory Convergence is RAPS’s annual multi-day gathering of the global regulatory community. RAPS is the perfect opportunity for our clients to meet and discuss with some of our experts and specialists. Join us in our booth (#625) to meet with us while we're at the conference. We cordially invite you to share your needs and ideas with us. We are looking forward to meeting you there!
Past Events - 2017:
The European Medical Device Regulation Conference
Join Florianne Torset-Bonfillou, Director of Regulatory, Education and Quality - Lead Auditor and Dr. Julien Senac, Certification Project Manager and IVD Product Assessor for a presentation on “Enhanced post-market measures & the involvement of notified bodies in the reporting process” and “ the Clarification on Device Re-classification under the new rules” This event will take place on July 13th and 14th , 2017 in Washington DC and is hosted by Q1 productions.
The semi-annual Medical Device Supplier Quality Conferences
Join Florianne Torset-Bonfillou, Director of Regulatory, Education and Quality - Lead Auditor at LNE / G-MED North America, Inc. for a presentation on the “Unannounced Audits of the Critical Suppliers: the Notified Body Perspective”.
These events will take place on April 20th in Virginia (VA) and on June 5th , 2017 in San Jose (CA) and are hosted by Q1 productions.
The MD and IVD Regulatory and Technical Forum
We are happy to announce our 3rd European MD and IVD Regulatory and Technical forum.
Come and meet us for one-day of regulatory and technical updates and information on June 7th, 2017 in California. Check out the program and speakers soon. Stay tuned!
The SMI 3rd conference on In Vitro Diagnostics
Join Dr. Julien Senac, Certification Project Manager and IVD Product Assessor at LNE / G-MED North America, Inc. for a discussion on the regulatory updates and key industry feedback from leading IVD manufacturers within this complex and ever-changing landscape at landscape at the SMI conference will take place the 14th and 15th of June 2017, at the Holiday Inn Kensington Forum, in London (UK). With the upcoming changes to the regulatory landscape, what does the future hold for the IVD manufacturers? SMi's In-Vitro Diagnostics (IVD) offers to discuss the latest update on the IVD regulation, the role of the Qualified Person (QP) as well as the increase in requirements for clinical evidence. This conference will focus on new regulation impact for IVD manufacturers and preparation to maintain compliance with the IVD regulatory requirements in a continuing and growing demand for use and innovation of IVDs.
Seminar on the future changes that will be introduced by the European MDR and IVDR
This seminar hosted by the RAPS San Francisco Bay Area Chapter, will take place on June 9th at the Crowne Plaza Silicon Valley (Milpitas, CA) and focuses on the Impact of the new EU Regulations (MDR/IVDR) on Notified bodies. Dr. Julien Senac, Certification Project Manager and IVD Product Assessor will speak about the changes introduce by the European MDR and IVDR from the Notified Body standpoint, discuss how Notified Bodies are preparing for the new regulation, and what manufacturer should focus in order to ensure that they can maintain compliance with the new MDR and IVDR technical documentation requirements.