Medical Device Software Engineering Conference
Q1 Productions | May 6-7, 2020 | CHICAGO, IL
Florianne Torset-Bonfillou Regulator & Education - Lead Auditor at GMED North America is a notified body speaker at this years "Medical Device and Diagnostic Labeling Conference," in Chicago, IL. She will be participating on the panel for, "Fireside Chat - Continuous Notified Body Clarification of MDR & IVDR Labeling Requirements."
With greater clarification on EU MDR and IVDR provisions as the deadline nears, manufacturers are continuously working to remain abreast of the evolving requirements while taking active steps to integrate updates accordingly, and remain compliant throughout the process. Areas of uncertainty remain however, relative to patient implant cards, acceptable symbols, use and unavailability of EUDAMED, pertinent data to submit in technical files and more. Through questions submitted directly by the audience ahead of the program, notified body representatives will share honest and transparent insight into matters of concern in order to ensure a compliant approach to European labeling mandates.
Medical Device Software Engineering Conference
Q1 Productions | February 25-26, 2020 | San Diego, CA
Dr. Sara Jafari AIMD Design Dossier Evaluator and Medical Device Certification Project Manager at GMED North America is a distinguished presenter at this years "Medical Device Software Engineering Conference," in San Diego, CA. She will be presenting on the topic, "Shedding Light on EU MDR Classification Changes for Medical Device Software Products."
To ensure compliance with EU MDR governance taking effect in May of 2020, the primary concern for software engineers in the medtech industry is with changes to medical device risk classification and the impact on embedded software and SaMD. By focusing on practical examples, discussing device classification changes, and defining which software features warrant particular classifications, engineers gain clarity on the process requirements for current devices and new classifications as well as specified steps for adherence.
• Understanding updated classification definitions and requirements
• EU MDR impact on new software development vs. current products
• Documenting the changes applied to software products for compliance
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GMED NORTH AMERICA FORUM - MDR & IVDR
November 18, 2019 | Palo Alto, CA
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.
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Regulation (EU) 2017/746 Training (IVDR)
October 15-16, 2019 | San Diego, CA
Sign up today and join our intensive 2 day course on the new European Regulation (EU) 2017/746 for In Vitro Diagnostic Medical Devices. Acquire a solid foundation so that you and your team are prepared to tackle through practical cases and working sessions/discussions led by our Expert lead auditor, these new challenges.
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Regulation (EU) 2017/745 Training (MDR)
October 15-16, 2019 | San Diego, CA
GMED North America has designed a comprehensive training course to help companies prepare for their application to obtain and/or maintain CE marking for their medical device product(s) by helping them gain an understanding of the changes introduced by both European Medical Device Regulation – EU MDR 2017/745, and assess the impacts of those changes on their organizational and structural activities.
RAPS Regulatory Convergence
21-24 September 2019 | Philadelphia, PA
The Regulatory Convergence Conference by RAPS is an annual multi-day gathering of the global regulatory community, the perfect opportunity to meet with our regulatory experts and discuss your certification project: CE marking, ISO 13485, MDSAP, Regulation (EU) 2017/745 on Medical Devices and 2017/746 on In Vitro Diagnostics etc. The #2019RAPS Regulatory Convergence Conference is, will be held at: Pennsylvania Convention Center, 1101 Arch Street, Pennsylvania. PA. Find us at booth #427 & book your meeting with our RA/QA Medical Device Experts!
9th Annual Medical Device and Diagnostic Labeling
May 14-15, 2019 | Chicago IL
Dr. Julien Senac, Certification Project Manager, IVD specialist and Medical Device Design Dossier Evaluator at GMED North America will present the "In-Depth Analysis of the EU MDR and EU IVDR Impact on Labeling Operations." at the 9th Annual Medical Device and Diagnostic Labeling Conference, hosted by Q1 Productions on May 14-15, 2019 in Chicago, IL. Dr. Julien Senac will also join the panel discussion on "Clarifying Specific Areas of Concern with Notified Bodies"
The EU MDR and IVDR have a significant impact on labeling operations with the introduction of provisions pertinent to symbols, enhanced language requirements, increased IFU content, and new documentation pieces such as the patient leaflet and implant card. In order to fulfill compliance in a timely manner, labeling teams require greater and more precise insight into areas of ambiguity, notably in the interpretation of unclear provisions and how to prepare strategies when critical platforms such as EUDAMED remain to be implemented. In the effort to shed light into the most prominent and timely challenges for labeling teams, notified body representatives will answer questions directly submitted by participants ahead of the conference.
Advanced EU MDR and CER Workshop
March 19th, 2019 | Boston, MA
Join Florianne Torset-Bonfillou, Director of Regulatory, Education and Quality for a discussion on “Enhanced post-market measures & the involvement of notified bodies in the reporting process”
The event will take place on March 19th and be hosted by MassMEDIC and Regulatory and Quality Solutions (R&Q).
Requirements for post-market surveillance have drastically changed under the EU MDR 2017/745. Manufacturers can no longer rely on a simple and systematic procedure to meet post-market surveillance requirements for their various types of devices –
MD manufacturers must now consider the unique aspects pertaining to each individual devices and assess how these may impact their post-market surveillance. Additionally, post-market surveillance activities must be an integral part of the clinical evaluation and risk management processes.
Data must flow between the CER, the risk management report, and the post-market surveillance which can be a challenge in large companies when it comes to the dynamics of communication between the different departments involved . So, how can manufacturers effectively implement all of this?
In this session, we will address the challenges manufacturers can face when implementing the EU MDR requirements for post-market surveillance. A panel of Experts will discuss the following questions:
• How to implement the requirement in a simple and straightforward manner;
• How to integrate CERs, PMS, and risk management processes and in what order?
• Trend reporting strategies – what will be acceptable?
• Do we include all CAPAs in reporting? Or shall only a small subset be included in the PSURs?
• To what extent shall complaint reporting be? What should be assessed and how much should be included?
• Post Market Clinical Follow Up (PMCF) – what can justify not doing it?
COMBINATION PRODUCT REGULATION CONFERENCE
February 28th- March 1st, 2019 | Arlington, VA
Join Waiss Faissal, a Certification Project Manager for Non Active Medical Devices, In- Vitro Diagnostic Devices, and the Drug Usefulness subject matter expert GMED North America for a presentation on the "EU MDR New Provisions and Effect on Combination Products." This presentation will be held at the Combination Product Regulation conference hosted by Q1 Productions.
The EU MDR introduces a completely new approach to combination product regulatory compliance within the territory, spanning all operations from product development to testing and CE mark approval. With the transition period ending in May 2020, regulatory affairs teams are prompted to revise and update strategies accordingly, demanding for a robust understanding of new provisions. Although both devices and pharmaceutical experts notice an increase in the workload due to the impending deadline, pharmaceutical organizations are more heavily impacted and face the challenge of entering a completely new regulatory framework. Some key focus areas are:
• Comparison between MDD vs MDR on combination products
• Actors involved in combination products assessment
• Change in the assessment process for drugs and devices
• Impact of MDR “Article 117”
The presentation will be followed by a panel discussion to share our knowledge and experience of the re-designation process.
RAPS Regulatory Convergence
1-4 October 2018 | Vancouver, BC
GMED 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!
Sessions and Book a Meeting, click here.
MedTech Summit
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.
Trainings
| 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 USA |
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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.
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