Clinical Investigations for Medical Devices

    4 – 6 October 2022, live online training

    Summary

    This three-day course will give you a thorough overview of the clinical evaluation process for medical devices against the requirements of the Medical Device Regulation. You will leave with an understanding of the clinical evaluation process including details on the regulatory requirements, the principles of clinical evaluation, study design, and practical considerations for how they are performed and documented.

    Learning Objectives

    • Identify the key requirements for clinical evaluation
    • Understand the relevant guidance documents
    • How to interact with regulatory bodies
    • Explain the principles of clinical evaluation
    • Outline the stages of the clinical evaluation process and documentation requirements
    • Determine whether or not a clinical investigation is required
    • Understand how clinical evaluation is performed, including details on clinical evaluation plans (CEP), demonstration of equivalence, identification and appraisal of data and analysis of clinical data
    • Understand when a clinical investigation is needed
    • Explain the post-market clinical follow-up (PMCF) requirements
    • Define the requirements of a clinical evaluation report (CER)

    Key Topics

    • MDR, MEDDEV 2.7/1 Revision 4 and relevant MDCG guidance documents
    • Medical device definitions
    • Post market clinical follow-up (PMCF) studies
    • Clinical evaluation report (CER)
    • Regulatory pathways & requirements (EU, US & UK)
    • Study design

    Who should attend?

    This course is suitable for all those involved in:

    • Medical Device R&D Engineers/ Scientists
    • Medical Device Quality Engineers
    • Clinical Trial Professionals
    • Regulatory Affairs Professionals
    • Quality Professionals

    Our online training experience includes

    • Our client zone – a single source for all training materials as well as pre and post-training communication
    • Live interactive format via the Zoom platform
    • Direct interaction with the trainer
    • Q&As, case studies, polls
    • Revisit recorded sessions for 30 days
    • Training in digital format
    • Digital and LinkedIn certificates

     

    Trainers

    Director, Medical Technologies EMEA
    Michael worked for Innovate UK for four years as a Health Innovation Lead and was responsible for the management of a UK government grant funding programme called the Biomedical Catalyst that provided £30M per annum to supports UK SMEs developing innovative health & life science products.  Before joining Innovate UK, Michael was a Group Manager at Medicines & Healthcare Products Regulatory Agency (MHRA) where he led a team that was responsible for safety & surveillance of all medical devices in UK.
    Health Sciences and Medical Devices Consultant
    James Pink has over 20 years of experience in the medical devices industry including 10 years as a healthcare technology expert and lead auditor for a leading European notified body.

    Clinical Investigations for Medical Devices

    Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

    Online Participation
    1 650  Price incl. VAT: 1 650 
    Equivalent of approx. 1 777 USD.
    The price calculation in USD is informative and might slightly differ from your bank exchange rate
    .

    Price per delegate including:

    Online participation

    Online workbook & materials

    Certificate

    Revisit recorded sessions for 30 days

    PC, microphone, camera, stable internet connection and the Zoom application.

    Yes, we will make every effort to ensure best possible interaction. You will see the slides, interact with the trainer and fellow participants. Questions and group exercises will be facilitated through the online meeting platform.

    Yes, you can transfer the registration to a colleague at any time.

    Yes, you may transfer your registration to a different event up to one month before the scheduled dates, provided the training fee has been paid in full.

    pharma learning leader

    Lydia Makori

    l.makori@symmetric.events
    +421 222 200 543

    Training Details
    • Start Date
      4. October 2022
      09:00 AM Vienna time
      08:00 AM London time
      03:00 AM New York time
      12:00 AM Los Angeles time
    • End Date
      6. October 2022