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GMED NORTH AMERICA FORUM

 November 18, 2019 | Crowne Plaza 4290 El Camino Real, Palo Alto, CA 94306

Calling on Medical Device enthusiasts of the European Regulatory framework

(RA/QA professionals, Medical Device Experts, Auditors and Manufacturers)

  GMED NORTH AMERICA FORUM November 18 2019 Palo Alto CA rev 2

 

We are happy to announce our Annual GMED North America Forum. Meet us for a day of Regulatory and Technical updates and information. We have created an exciting program with a strong emphasis on the new (EU) Regulations 2017/745 for Medical Devices and 2017/746 for In- Vitro Diagnostic Devices. The forum format will feature presentations by our GMED national and international regulatory experts with facilitated workshops.

Register Now 

 

                                                              Agenda

8:00-8:30 a.m.

Breakfast

8:30-9:00 a.m.

Opening statements

9:00-10:00 a.m.

Article 120 & 110 Implementation:

Transition to EU Regulations 2017/745 (MDR) & 2017/746 (IVDR)

10:00-10:45 a.m.

Manufacturer guest speaker

10:45-11:00 a.m.

Break

11:00-12:00 p.m.

Clinical evaluation under the aegis of the new Regulation (EU) 2017/745 on Medical Devices

12:00-1:00 p.m.

Lunch

1:00-2:00 p.m.

Applicable standards for active medical devices for CE marking

2:00-3:00 p.m.

Workshops

(Session 1)

Medical Device Usability - Latest Standards and European Requirements 

Clinical evaluation under the aegis of the new Regulation (EU) 2017/745 on Medical Devices

Person Responsible for Regulatory Compliance (PRRC)

3:00-3:30 p.m.

Break

3:30-4:30 p.m.

Workshops

(Session 2)

Medical Device Usability - Latest Standards and European Requirements     

Clinical evaluation under the aegis of the new Regulation (EU) 2017/745 on Medical Devices

Person Responsible for Regulatory Compliance (PRRC)

4:30-5:15 p.m.

Roundtables

(Per Specialty)

Regulatory & Quality

Auditor

Technical Documentation Assessor

5:15-6:30 p.m.

 Closing

 

  

 Speakers                    Topics                              Descriptions

Amelia C

Amelia Kara

Clinical Data Evaluator

The Clinical evaluation under the aegis of the new regulation.

It is undeniable that the clinical evaluation takes the lion's share of novelties in the European  Regulation (EU) 2017/745. The criteria of equivalence are much more restrictive which will lead to an explosion of the number of clinical investigations in the coming years. Post-Market clinical follow-up  is not left out with the appearance of PSUR, SSCP,  Eudamed database... etc.. The landscape of the medical device is about to change drastically. Take part in our workshop and learn how to navigate clinical evaluations under the MDR. Case studies will be provided to ensure maximum understanding of expectations regarding clinical evaluation reports.

chris 1 c

Chris Brodrick

Technical Documentation  Assessor

Sarah C

Sara Jafari

Certification Project Manager

Medical Device Usability: Latest Standards and European Requirements

Medical device manufacturers marketing in Europe may apply usability standards to demonstrate compliance with essential requirements of medical device regulations. During this session an overview of Usability Standards, MDR requirements related to usability and application of usability engineering process to medical devices will be discussed. The session will be followed by a workshop.

Seb C

Sebastien Rosset

Certification Project Manager/

Lead Auditor

Applicable standards for active medical devices for CE marking

This topic will help you to appropriately take into account the standards applicable to your product in order to identify in advance the key success factors to exporting your medical device in Europe. This topic will cover the list of harmonized standards in Europe, and provide useful information on how to prepare your dossier before carrying out the tests.

F C

Florianne Torset- Bonfillou

Regulatory, Education
and Quality - Lead Auditor

Article 120 & 110 Implementation:

Transition to EU Regulations 2017/745 (MDR) & 2017/746 (IVDR)

The entry into force of the MD and IVD Regulations took place on May the 25th, 2017, with a transition period of 3 years for the Medical Devices including Active Implantable Medical Devices; and 5 years for In Vitro Diagnostic Medical Devices. From their application date, respectively 2020 for the Medical Device Regulation and 2022 for the In Vitro Diagnostic Regulation. Certificates issued during the transitional period will have a validity period which cannot exceed 2024, irrespective of the Directive or conformity assessment procedure claimed by the manufacturer. Article 120 of the Medical Devices Regulation and Article 110 of the In Vitro Diagnostic Regulation describe each of the transitional provisions applicable. This presentation will focus on the key elements to be considered by MD & IVD  Manufacturers to successfully navigate through the transition.

Pas C

Pascal Bisson

Certification Project Manager

Person Responsible for Regulatory Compliance (PRRC)

Articles 11 to 16 of the EU MDR 2017/745 are bringing brand new sets of requirements related to stakeholders other than the manufacturer, involved in the Medical Device lifecycle. The stakeholders themselves are not new but their responsibilities are now part of the Regulation. During this workshop, you will have the opportunity to work on and discuss with your peers about the new requirements related to economic operators and to the person responsible for regulatory compliance. Key requirements will be reviewed with discussion on implementation.

 

Register Now 

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

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Due to our rapid growth in North America, we're seeking Lead Auditors.