clinical investigation evaluation medical device

    Clinical Investigations and Evaluation for Medical Devices

    28 – 30 March 2023, 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

    • Gain an update on the regulatory requirements
    • Understand different study types
    • Determine whether or not a clinical investigation is required
    • Understand sufficient quality & level of evidence requirements
    • Determine technical, biological, and clinical evidence for a development plan
    • Understand ‘state of the art’ in medicine
    • Assess the usability of medical devices registries

    Key Topics

    • Regulatory requirements & pathways (EU, US and UK)
    • Study types & design
    • Clinical evidence – clinical development plan, clinical benefits
    • Clinical investigations – process, risk, parameters & design
    • Post-market surveillance
    • Medical device registries

    Who should attend?

    This course is suitable for all those involved in:

    • Clinical Studies/Trials/Affairs Professionals
    • Regulatory Affairs Professionals
    • Quality Professionals
    • R&D 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

    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.
    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 investigation evaluation medical devices

    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
    1 850  Price incl. VAT: 1 850 
    Equivalent of approx. 2 056 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
      28. March 2023
      09:00 AM Vienna time
      08:00 AM London time
      03:00 AM New York time
      12:00 AM Los Angeles time
    • End Date
      30. March 2023
    What participants said about this course

    "Thanks for the good environment you set up during the prentation. Special thanks for the technical aspect of the training."
    Associate Director Clinical Operations, Endotronix

    "Thank you for a very informative training course. The timing of start/break/finish was perfect."
    Clinical Project Manager, Regen Lab

    "Thank you for the sessions and for the admin behind the scenes."
    Senior Manager Regulatory Affairs, Leica Microsystems

    "Really enjoyed the course."
    Director Clinical Affairs, Lava

    "Very interactive format since the trainer answered questions as they came in and so it was more "hands-on"."
    Clinical Affairs Manager, Flen Health

    "The topics covered were very relevant to my day job and this is my first formal training so I appreciated going indepth. I thought Day 2 linking between the MDR and the presentation was really helpful."
    Business Developer, Monivent

    "Well run and half day seesions for busy professionals is a good idea. Great resourses and video capture means if we missed parts we can review."
    Clinical Sciences Lead EMEA, Cordis