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Meet our speakers!

Vancouver Convention Centre West |Canada| October 1 - 4, 2018 |

Booth #415

GMED North America is coming into force at RAPS 2018 Regulatory Convergence

The Regulatory Convergence is RAPS’s annual multi-day gathering of the global regulatory community and the perfect opportunity to meet with our technical experts and discuss your certification project (CE marking, ISO 13485:2016, MDSAP)

Our Regulatory and Technical Experts will be speaking
at the following sessions:

Julien Senac LNE Gmed

Dr. Julien Sénac

PhD, Certification Project Manager
IVD Product Assessor

Demystifying the EU MDR and IVDR: From Transition to Implementation

Workshop

Monday, October 1

9:00 AM - 5:00 PM

LDTs: US-based Labs Will have to Follow US and EU Regulation - Convergence and Divergence

Conference

Thursday, October 4

8:30 AM - 9:30 AM

“Legacy” IVD Products: Strategy to Obtain Clinical Data in View of CE Certification Under the IVDR

Conference

Thursday, October 4

11:00 AM - 12:00 PM

Florianne Torset Bonfillou LNE Gmed

Florianne Torset- Bonfillou

Director of Regulatory and Education
Lead Auditor

Technical Documentation Requirements Under the European In Vitro Diagnostics Regulation

Conference

Thursday, October 4

1:30 PM - 2:30 PM

Sara Jafari LNE Gmed

Dr. Sara Jafari

PhD, Certification Project Manager (AIMD)

 

Is My Software a Medical Device? New Laws, Regulations and Guidance Documents That Can Impact Your Business's Future

Conference

Thursday, October 4

11:00 AM - 12:00 PM

 

Waiss Faissal LNE Gmed

Waiss Faissal

PharmD, Certification

Project Manager

Implementation of the New Medical European Regulation in Non-European Member States

Conference

Thursday, October 4

10:30 AM - 11:30 AM

 

 

Book a Meeting Today!

Working in today’s Medical Device industry is more challenging than ever. Medical Device manufacturers must define early on, through a dedicated and methodical approach, their objectives to maintain compliance and compete in the medical device marketplace. If you plan on attending RAPS 2018 Regulatory Convergence conference and would like to drop by for a chat and learn how GMED NA can help your business achieve more and stay competitive, fill out our 'Schedule a Meeting' form and we’ll be happy to meet with you. You will find us in booth #415

 


Anthony Delamotte LNE G-MED

Ehab Amen LNE Gmed

Anne Le Rouzo LNE Gmed

Anthony Delamotte

Certification Department Director

Ehab Amen

Operations Director

Anne Le Rouzo

Lead Auditor

Senior File Assessor


Laetitia Devaux LNE Gmed

Nathalie Morin LNE Gmed

Tarik Krim LNE Gmed

Laetitia Devaux

Quality Leader

Nathalie Morin

Certification Project Manager

Tarik Krim

CEO

 

Book a Meeting:

We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States

Get a quote proposal

   1-301-495-0477

MDSAP Prepare the transition, worldwide market access

clientsWe're Hiring!

Due to our rapid growth in North America, we're seeking Lead Auditors, Certification Project Manager Active and Certification Project Manager - In Vitro Diagnostics responsible for medical device manufacturing clients.