Technical Management
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Explore, strengthen your expertise and innovate with Efor Webinars

Efor Group’s Technical Management is offering a series of free webinars open to all. Hosted by our industry experts, these webinars offer a unique opportunity to deepen your knowledge and discover the latest innovations and our advice for ensuring the performance and safety of your products in the light of the latest regulatory developments. Find out about upcoming webinars and register for free.

Our next webinars

Our previous webinars

  • 10/04/23-MDR 2017/745&746: quality management system: the home stretch!

    In this period of transition from regulations 2017/745 & 746, we understand the complexity of your challenges. At your side, but also in contact with notified bodies, we want you to benefit from our feedback to prepare for the 1st deadline
    of May 2024 around the quality management system.

    We will cover the following topics:
    1. Reminder of the regulatory and standards context, and points to watch out for in the run-up to the May 2024 deadline.
    2. Feedback from initial feedback from notified bodies
    3. Our tips for maintaining a high-performance operational system

    The introduction to this event, “A reminder of the transition period”, will be given by
    Cécile Vaugelade, Snitem’s Director of Technical and Regulatory Affairs.

    To find out more and access the recording (in french only), contact us.

  • 01/18/24-Understanding the requirements of the new Medical Device Regulation

    Are you ready to distribute your medical device to the EU market?

    What is the EU approach to get medical device CE marking ? 

    What are these EU requirements and how can manufacturers best address them ?

    “Medical devices” : same name, different requirements…

    The Medical Device Regulation (MDR) 2017/745 replaced the former Medical Device Directive (MDD) 2001/83/EC and has globally increased requirements on medical devices and obligations of all medical device actors and operators.

    Join us for the first (FREE!) webinar entitled “REQUIREMENTS OF THE NEW MEDICAL DEVICE REGULATION” in our 3-part series on January 18th, 2024 at 9:30 EST to better understand:

    Key definitions (medical device and classification)

    The key actors in the EU on medical devices with Roles and responsibilities

    • – Impacts on devices already cleared under MDD
    • – How to ensure compliance to the famous GSPRs
    • – The content of a Technical file under MDR 2017/745 
    • – What about UDI and EUDAMED?

    The webinar will be presented by Yannick SPENNINCK (North America Technical Director & Expert on medical devices) and Iphigénie HUSSON (Sr. RA consultant and EU Regulation expert).

    To find out more and access the recording (in english only), contact us.

  • 01/25/24-Understanding biocompatibility, toxicology and usability requirements of MDR 2017/745

    Many US medical device manufacturers hesitate to place their products on the European market. Why? There are many different reasons, and among them uncertainties related to the biological evaluation and usability requirements of medical devices . What are the requirements in terms of verification and validation, specifically regarding Biocompatibility and Usability requirements? Does the new 2023 version of the FDA guidance on ISO 10993-1 (biocompatibility) have an impact on obtaining a CE mark? And what about the requirements of IEC 62366?
     
    This second (FREE!) webinar in our series “Certifying Medical Devices in Europe” on January 25, 2024 from 9:30-11:00 am EST shall provide a dual perspective on biocompatibility and usability requirements from two of our technical experts, Eléonore MICHEL and Jean-Charles DOMENGET.
     
    Biocompatibility topics:
    1. Main differences in requirements between FDA guidance on ISO 10993-1 and the standard itself
    2. Changes applied in the new 2023 version of the FDA guidance and expected changes on the ISO 10993-1, currently under revision.
     
    Usability topics:
    1. How to meet the MDR 2017/745 requirements of IEC 62366?
     
    Benefit from our expertise in biological evaluations and usability and let us accompany you in obtaining your CE mark!
    Eléonore MICHEL is Technical Expert and Manager in biological evaluations and toxicology, and Jean-Charles DOMENGET is Technical Expert in Usability for medical devices.
    To find out more and access the recording (in english only), contact us.

  • 02/01/24-Understanding the clinical evaluation requirements of MDR 2017/745

    Medical Device Regulation (MDR) 2017/745 has increased requirements regarding the clinical evaluation of medical devices. What are these requirements and how can manufacturers best address the specificities of MDR 2017/745?
     
    Join us for the third (FREE!) webinar in our series “CERTIFYING MEDICAL DEVICES IN EUROPE” on
    February 1, 2024 to better understand:
    • – The clinical evaluation process and regulatory rationale
    • – Key differences between clinical evaluations in Europe and the US
    • – The essentials of the various clinical evaluation documents required under MDR 2017/745 (CEP, CER, PMCFP, PMCFR, SSCP)
    • – What clinical evidence needs to be presented in order to meet MDR 2017/745 requirements?
    • – What is Post-Market Clinical Follow-up? When and what types of activities are required?
    • – The role of the notified body and specific requirements
    The webinar will be presented by Katharina HOEGL, Expert and Technical Manager in clinical evaluations for medical devices. 
    To find out more and access the recording (in english only), contact us.

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