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    Clinical Investigations 101

    CLINICAL INVESTIGATIONS

    Are you considering a clinical investigation for your medical device but unsure where to start? Would you like some help figuring out which aspects to outsource and what steps to take before contacting a Contract Research Organization (CRO)?

    This short self-study course, consisting of 8 modules, is intended to help those who work with new medical devices and are unfamiliar with the complex world of planning, execution and reporting medical device clinical investigations.

    If you are planning a clinical study for your device, this course will equip you with essential concepts and terminology and offer guidance on contacting a CRO that can help your product succeed.

    Please note that Clinical Investigations 101 focuses on the investigations of medical devices. It does not cover the specifics of IVD medical device clinical performance studies.

    Topics of this session

    • What is a clinical investigation of medical devices?
    • The types of clinical investigations
    • Clinical study timeline
    • Planning a clinical investigation project
    • Preparing a budget for a clinical study
    • Mandatory competences required for a clinical study
    • The connection between clinical investigations and a technical file
    • Common pitfalls to avoid
    Register

    Trainers

    Markus Vattulainen
    Markus Vattulainen
    Data Manager
    markus.vattulainen@aurevia.com

    Markus Vattulainen is a Data Manager in Labquality's CRO business. His responsibilities include designing clinical device research, modeling research data flows, server environments, data collection systems (ECRF), document management systems (TMF, ISF), programmatic controls for data quality, technical data security, and data protection for clinical research (GDPR).

    Maria Malm
    Maria Malm
    Clinical Study Manager
    maria.malm@aurevia.com
    Annika Astola
    Annika Astola
    Team Lead, CRO Services
    annika.astola@aurevia.com

    Target group

    Clinical Investigations 101 is designed to teach how to start a clinical investigation. This makes the course particularly useful for medical technology start-ups, research-to-business projects (R2B), university spin-offs, and anyone preparing to launch their first medical device in the EU market.

    After this session, you

    • Will know the basics for successful clinical investigations
    • Are familiar with the core concepts of clinical investigations and terminology
    • Have basic knowledge of planning, scheduling and budgeting a successful clinical study
    • Are able to pinpoint the outsourced expertise needed for your project
    • Know what to have in place before contacting a CRO

    What next?

    You might also be interested in 

    Clinical evaluation of medical devices according to MDR & MEDDEV 2.7/1 Rev. 4
    A one-day intensive training about all related matters regarding the preparation of a clinical evaluation for a medical device including a workshop.
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    Clinical Research under MDR and ISO 14155:2020
    A one-day intensive training about all related matters regarding clinical research aspects with medical devices, including a practical workshop.
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    Regulatory Essentials in Health Tech: Clinical Investigations in Practice
    Read more

    Billing and cancellation policy

    Read the billing and cancellation policy for online trainings here.

    Participation in the training can be cancelled two weeks (14 days) before the event free of charge. For cancellations made after this, we will charge 50% of the participation fee, except for cancellations made one week before the event, we will charge a 100% participation fee.

    Cancellations are always made in writing to: koulutus@aurevia.com.  
    The participating organization may, if it wishes, change the participant free of charge by notifying it in writing before the event to:  koulutus@aurevia.com. The participation fee will be invoiced immediately after the event. The training session will be confirmed to the participant by e-mail about a week before the event.  Labquality reserves the right to cancel the training session due to a small number of participants.