<img alt="" src="https://secure.52enterprisingdetails.com/787780.png" style="display:none;">
Skip to content
    en

    Solutions for Medical Device Manufacturers

    Our team of experts serves medical device manufacturers by providing high-quality clinical research and regulatory services covering the entire product lifecycle.
    Contact us

    Solutions tailored to your needs

    Our quality assurance, regulatory affairs, and clinical research experts work together to create the most efficient solutions for you. We are a multidisciplinary team with proven industry expertise and experience. Our dedicated professionals are ready to deliver results, always collaborating closely with each customer at the centre. Whether a standalone project or a long-term collaboration, we support you in every phase of your regulatory and clinical research journey to enable you to achieve 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 standardisation. Our highly qualified QA/RA professionals have the experience and expertise to provide you with effective and tailored solutions.

    Quality Manager as service

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

    Project-based QA/RA support

    Our consultants support your QA/RA operations together with your QA/RA team. The service can be fully customized and may include, 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 devices 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.
    CONTRACT RESEARCH ORGANISATION (CRO)

    Medical Device CRO

    We have the medical device expertise to help you with all aspects of your clinical investigations from planning, designing and executing through to analysis and reporting. We have extensive experience with all types of clinical investigations including first-in-human studies, feasibility or pilot studies, randomized controlled clinical investigations, and registry studies. We can also support you with your clinical evaluations, as well as partnering with you to build the right clinical development strategy for your medical device.

    Our clinical investigation services include:
    • Project management
    • Medical writing, including preparation of all necessary documentation
    • Feasibility and site evaluation
    • Regulatory submissions
    • Regulatory services
    • Monitoring and site management
    • Data management and biostatistics
    • Vigilance
    labquality_com_15

    Data management

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

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

    Medical writing

    We have a thorough understanding of regulatory requirements, and the medical writing expertise to support your documentation across your entire product lifecycle.

    • Regulatory documentation
    • Clinical study documentation
    • Publications
    Read more
    female-entrepreneur-talking-colleague

    Clinical evaluation

    A clinical evaluation is the link between the technical file and clinical investigation. We provide services for 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

    See also

    Our experience with different indications and medical devices. Read more >>

    Contact us for more information

    Meeri Säily
    Meeri Säily
    Sales Director

    Leave a contact request