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    Online training on the basics of the IVDR (EU) 2017/746 requirements

    MEDICAL DEVICES

    Are you aware of the impact of IVDR on your business? The new EU IVDR will bring several changes and affects the IVD economic operators in the entire supply chain, like manufacturers, distributors, importers and suppliers. To support operators to comply with the new IVDR requirements, Labquality will offer an online training course consisting of six sessions. The Labquality training course helps your company understand the key changes and their impact on your business.

    The training will provide participants with an overview of the critical changes in relation to new EU IVDR. You can participate in the complete training course or pick the most suitable sessions for you. Sign up for the complete training course here or use the button below. If you want to participate in the individual sessions you can choose the ones you are interested in from the links under the session descriptions.

    If you order the complete course by 26 September 2022, you will get a -25% discount using the coupon code IVDR2021. 

    Topics of this session

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    Trainers

    Mari Kukkonen
    Mari Kukkonen
    Quality and Development Manager
    mari.kukkonen@aurevia.com
    ”Olen tuotekehityksen, lääkinnällisten laitteiden ja laadunhallinnan asiantuntija. Minulla on kokemusta MD- ja IVD-teollisuudesta kirurgisten instrumenttien, implanttien ja nukleiinihappoteknologiaan perustuvien IVD-testien valmistuksen parista. Lisäksi olen työskennellyt lääkinnällisten ohjelmistojen ja monen muun lääkinnällisen tuotteen vaatimustenmukaisuuden parissa. Olen perehtynyt tuotteen koko elinkaareen aina tuotekehityksestä tuotantoprosesseihin, laadunvarmistukseen ja tuotannon jälkeiseen seurantaan. Erityisosaamisalueitani ovat tuoteriskinhallinta (ISO 14971), laadunhallintajärjestelmävaatimukset (ISO 9001, ISO 13485), sisäiset auditoinnit, puhdastilojen ylläpito ja valvonta (ISO 14644, GMP) sekä biologinen arviointi (ISO 10993). Minulla on vahva tutkimustausta ja olen väitellyt tohtoriksi genetiikasta (FT).”
    Anja Kontio
    Anja Kontio
    Quality and Regulatory Affairs Manager
    anja.kontio@aurevia.com
    ”Olen pitkän linjan laadunhallinnan ammattilainen. Olen työskennellyt lähes 30 vuotta IVD-teollisuudessa erilaisissa laadunhallinnan ja regulatorisissa tehtävissä ja laatujärjestelmien kehittäminen on ollut tärkeässä roolissa koko urani ajan.  Minulle on urani aikana kertynyt kattava auditointikokemus (ISO 13485, USFDA QSR, MDSAP) toimiessani auditoijana ja ollessani auditoitavan roolissa. Minulla on myös ammatillisen opettajan pätevyys.”

    Target group

    Our training is intended for quality and regulatory affairs managers and specialists, IVD designers, project managers, marketing managers, operations managers, and other responsible persons working in the IVD industry, and for other economic operators in the supply chain who need to understand at least the basics of the IVDR. Participants will receive a course certificate via email after the course. All attendees are granted free and unlimited access to Entries, the Digital Regulatory Runways for the duration of a full year.

    After this session, you

    The participants will understand the impact of the new In-Vitro Diagnostic Regulation (IVDR), the most relevant changes compared to the directive, and how the IVDR will impact medical devices already on the market as well as new medical devices.

    What next?

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    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.