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    Medical devices

    Clinical evaluation

    This half day course, in cooperation with Swedish Medtech, will help you gain knowledge about the requirements on clinical data and clinical evaluation.
    The Medical Device Regulation (MDR) emphasizes the requirement for sufficient clinical evidence for any device to get CE marked. Clinical data are normally needed for being compliant with the general safety and performance requirements (GSPR) of the regulation.

    A clinical evaluation is mandatory for all devices and the main output document, the clinical evaluation report, states whether there is enough clinical evidence to support the clinical safety and performance of the device.

    Clinical evaluation is on ongoing procedure to collect, appraise and analyse clinical data of pertinence for the medical device. There is a strong relationship between clinical evaluation, risk management and post-market surveillance.

    Topics

    • Clinical evaluation – an overview
    • Regulatory context
    • Clinical data
    • Device-specific adaptation
    • Equivalence
    • Post-market clinical follow-up
    • How to perform a clinical evaluation – step by step

    Trainers

    Cecilia Emanuelsson
    Cecilia Emanuelsson
    Principal Consultant
    Cecilia has extensive knowledge of medical devices with specific focus on patient safety aspects from a clinical perspective. Her experience covers MDD/MDR and IVDD/IVDR devices of all risk classes, including implants and medical device software. Cecilia has a scientific background with many years of experience from academic research.

    Target group

    Quality and regulatory professionals working with medical devices, and other medical device company employees interested in the topic. The course is developed for participants who have a basic knowledge of medical device development and medical device legislation.

    Objectives

    After the course, participants will have a general knowledge of the requirements on clinical data and clinical evaluation. They will also have a basic understanding of how to perform a clinical evaluation.

    Additional information

    The course costs 5 800 SEK. For Swedish Medtech member companies, the course costs 4 100 SEK. All prices are excluding local VAT. Course material will be in English, with verbal presentation and discussions in Swedish.

    Related courses

    Technical documentation for medical devices
    This one-day course, in cooperation with Swedish Medtech, is tailored for RA and QA specialists who are relatively new to development projects for medical devices. You will gain a clear understanding of how technical documentation is built throughout the development process – from concept to market approval.