Clinical Evaluation for Medical Devices

    Event Link: https://www.meddevsolutions.co.uk/payment?product_id=jan-clinical-evaluation

    To secure your place at this event, please follow the ‘event link’ above and complete the booking form on the event website to secure your seat. This event is not free to attend and a confirmation from LinkedIn does not confirm your registration for the event.**

    Course Overview:

    Are you struggling to navigate the clinical evaluation requirements under the EU MDR? Has your notified body given you feedback that you do not know how to deal with?

    Our Medical Device Clinical Evaluation training course will help you to understand and equip you with the knowledge, skills, and expertise required to conduct rigorous and compliant clinical evaluations of medical devices.

    Throughout this training, we delve into the core principles and practices that underpin effective clinical evaluations, while addressing the latest regulatory requirements, real world examples and best practices in the field.

    Course Agenda

    Day 1
    What is Clinical Evaluation?
    Definitions and Key Terminology
    Clinical Evaluation Process
    Clinical Evaluation and the MDR
    Equivalence
    Links to other processes

    Day 2
    Clinical Evaluation Plan
    Plan Objectives
    Data Sources
    Claims
    GSPRs
    State of the Art

    Day 3
    Safety and performance outcome parameters
    Literature Search & Databases
    Develop your question – PICO
    Identification of Data
    Appraisal & Analysis
    Risk of Bias

    Day 4
    Clinical Evaluation Report
    Determining sufficient evidence
    Post Market Clinical Follow-up (PMCF)
    Summary of safety and clinical performance (SSCP)
    Clinical evaluation guidance
    Best practices
    Notified Body perspective

    What’s included?

    – 4 half days of live online training
    – Copy of the presentation
    – Host of additional materials
    – PDF Certificate of completion
    – Join in polls, tests and breakout rooms
    – Q&A session

    What you need:

    ▪ Access to Zoom
    ▪ Access to a microphone (Webcam not required)

    Who should attend?

    This course applies to anybody that requires an understanding of clinical evaluation and provides you with a solid foundation.

    Audience learning level: Basic to intermediate

    Discounts:
    Discounts are available for 3+ attendees. Please email us at info@meddevsolutions.co.uk for your unique discount code to use at the checkout.

    Event Details
    • Start Date
      January 22, 2024 2:00 pm
    • End Date
      January 25, 2024 6:00 pm
    • Status
      Expired
    • Price
        £895
    • Organizer
    Leave a Comment

    Event Details
    • Start Date
      January 22, 2024 2:00 pm
    • End Date
      January 25, 2024 6:00 pm
    • Status
      Expired
    • Price
        £895
    • Organizer
    en_USEnglish