Skip to content
    fi
    RATKAISUT

    Lääkinnällisten laitteiden valmistajille

    Asiantuntijatiimimme palvelee lääkinnällisten laitteiden valmistajia tarjoamalla korkealaatuisia palveluja tuotteiden sääntelyn elinkaaren vaiheisiin.

    Ota yhtyettä

    Solutions tailored to your needs

    Our quality assurance, regulatory affairs and clinical investigation experts work together to create the most efficient solutions for you: We are a multidisciplinary team with solid industry experience. Our flexible professionals are ready to deliver service, and always work with the customer at the centre. Whether a one-time assignment or a long-term collaboration, we support you in every phase of your regulatory & research journey to reach your business goals.

    We provide you with support starting from the first idea of the product until the end of the product life cycle.

    QA/RA Services for Medical Device Industry

    We help you manage any new guidance, regulations and standardization. The number of qualified QA/RA professionals is limited, but we have the capacity to provide you effective and tailored solutions.

    Quality Manager as service

    Outsourced Quality Manager service frees up your resources. Your Quality Manager works as part of the organization, collaborating with the leadership and others to ensure regulatory compliance, and manages your QMS.

    Project-based QA/RA support

    Our consultants support your QA/RA operations together with your QA/RA team. The service can be fully customized, potentially including for example

    • regulatory strategies to adapt changes in the regulative environment
    • technical documentation
    • new product design control support
    • global registrations and related documentation updates
    GLOBAL REGISTRATIONS

    Are you expanding to new markets?

    All markets have their requirements for medical devices, reaching beyond the EU CE mark or US FDA clearance/approval. As we have registered medical in more than 60 countries, we can help you enter new markets.
    Read more
    MEDICAL DEVICE & IVD MANUFACTURERS

    Explore our services for the lifecycle of a medical device

    We provide you with support starting from the first idea of the product until the end of the product life cycle.

    CRO-palvelut lääkinnällisille laitteille

    We are a full service CRO working not only with medical devices but also IVDDs and pharmaceuticals.

    labquality_com_15

    Data Management

    We are your one-stop shop for all clinical investigation data management needs.

    • General data management
    • Data protection
    • Biostatistics
    Read more
    labquality_com_22

    Medical writing

    We have experience in merging data and regulatory requirements into compliant documentation across the entire lifecycle of the device.

    • Regulatory documents for clinical investigations
    • Publications
    Read more
    labquality_com_19

    Clinical Evaluation

    A clinical evaluation is the link between the technical file and clinical investigation. We provide services in the planning, preparation and conduct of clinical evaluations.

    Read more
    elderly-health-checkups-with-physician-psychia

    Clinical investigation

    Our offering covers planning, development, conduct and reporting of medical device clinical investigations in accordance with the ISO 14155:2020 standard and considering MDR and national requirements.

    Read more

    Ota yhteyttä ja kysy lisää!

    Meeri Säily
    Meeri Säily
    Sales Director, Consulting and Clinical Trials

    Yhteydenotto