Why choose Kiwa Medical

Choose Kiwa Medical as your Notified Body partner and embark on a journey that transforms regulatory compliance into a strategic advantage. Our commitment to excellence, regulatory prowess, and client-focused approach makes us the ideal partner for bringing your medical devices to market successfully.

At Kiwa, we want to help companies and organization go forward. We are committed to a safer and a more sustainable world. That also applies for the medical devices sector. Kiwa Medical is your global partner, providing worldwide conformity assessment activities.

Kiwa Medical - Value Proposition Statement

Our commitment to excellence, regulatory prowess, and client-focused approach makes us the ideal partner for bringing your medical devices to market successfully.

At Kiwa Medical we understand that bringing a medical device to market is a complex and highly regulated process.

Our Notified Body services are designed to empower your journey, ensuring compliance with the latest regulatory standards, while streamlining the certification process.

This is how we add value to your medical device development

    Exceptional regulatory expertise

    Benefit from our team of experienced regulatory professionals who have in-depth knowledge of the ever-evolving medical device regulations. We are up to date of the latest changes, enabling you to navigate the regulatory landscape with confidence.

    Guidance throughout the certification process

    We provide support at every stage of your certification trajectory: from initial assessments to post-market surveillance.

    Efficient and timely approvals

    Time-to-market is critical in the medical device and healthcare industry. Our streamlined processes and our proactive approach, ease faster approvals, helping you get your certificate.

    Comprehensive range of services

    Our Notified Body services cover a wide array of medical devices, from simple devices to complex systems. Whether you are developing diagnostic equipment, implantable devices, or software-driven solutions including Artificial Intelligence, we have the expertise to guide you through the certification process.

    International recognition and market access

    Gain access to international markets with confidence. Our Notified Body certifications are recognized internationally, opening doors to new opportunities, and enabling you to expand.

    Responsive and client-centric approach

    Experience a service that prioritizes your needs. Our client focused approach ensures that your questions are answered in a timely manner, and your concerns are addressed with the attention they deserve. We are committed to fostering a collaborative partnership to achieve shared success.

    One stop shopping

    We have test laboratories spread across multiple counties to help you to ensure that your products comply with the specific standards and regulations. As more products are connected to the world, we can offer you services relating to cybersecurity and artificial intelligence as well.

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Would you like to know more about our services in the field of medical devices? Please contact us using this form.