11/15 June 2018 I Brussels, Belgium.
Join Dr. Julien Senac, Certification Project Manager and IVD Product Assessor at LNE / G-MED North America, Inc. for a discussion on “Notified Body perspective: Preparing for re-designation and latest status of the application process” during MedTech Summit, an event taking place the week of June 11th, 2018 in Brussels, Belgium.
This presentation will explore:
- The current status of the re-designation process and its timeline
- The application process and which NBs have applied or withdrawn from the process
- The strategies and coordinated approaches taken by NBs to apply for re-designation
- The practical experiences and challenges with re-certification under the new EU MDR
- The impact of the re-designation on the issuance of MDD and MDR certificates for Medical Device Manufacturers
The presentation will be followed by a panel discussion to share our knowledge and experience of the re-designation process.
2nd EU MDR implementation Conference
July 12/13 2018 I Alexandria, VA
Join Dr. Julien Senac, Certification Project Manager and IVD Product Assessor at LNE / G-MED North America, Inc. and Florianne Torset-Bonfillou for a discussion on “Engaging in the practical implementation of new labelling requirements under the MDR” and “revising post-market surveillance and vigilance”.
This event will take place during the 2nd EU MDR Implementation Conference hosted by Q1 productions, in Alexandria, Virginia.
With the new EU Medical Device Regulation, the importance of providing end-users with critical information for the safe and proper use of a medical device is taken to a new level. Requirements span new end-user and device-specific data impacting clinical and quality operations, new label formats, as well as an enhanced definition of labeling materials now extended to any published information about the product, impacting marketing. With such a prominent position given to labeling in the regulation, regulatory professionals must secure a clear interpretation of mandates to efficiently lead the progression towards compliance. Likewise, the revision of the post-market surveillance and vigilance impacts directly medical device manufacturers, with a new reporting frequency as well as the additional requirements with regard to post-market and vigilance, they need to establish a robust post-market data management plan.
1-4 October 2018 | Vancouver, BC
LNE/G-MED NA will participate to RAPS 2018 Regulatory Convergence in Vancouver, BC (Canada). The Regulatory Convergence is RAPS’s annual multi-day gathering of the global regulatory community. This year Convergence is being held in Vancouver, BC 1–4 October, at the Vancouver Convention Centre. It will feature presentation of representatives from the world’s leading health authorities: FDA, EMA, Health Canada and Notified Bodies. RAPS is also the perfect opportunity for our clients to meet and discuss with some of our experts and specialists. Join us on our Booth #415 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:
|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|
Meet our team members at:
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!
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.