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 Service

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. Here is how we add value to your medical device development: 

  • Exceptional regulatory expertise: Benefit from our team of experienced regulatory professionals who possess 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.
  • Support and guidance throughout the certification process: We provide support at every stage of your certification trajectory: from initial assessments to post-market surveillance. Our experts work closely with your team, offering guidance to address specific challenges and ensure a smooth certification process.
  • 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 covers a wide array of medical devices, from simple devices to complex systems. Whether you are developing diagnostic equipment, implantable devices, or software-driven solutions, we have the expertise to guide you through the certification process.
  • Global recognition and market access: Gain access to global markets with confidence. Our Notified Body certifications are recognized internationally, opening doors to new opportunities, and enabling you to expand your reach without facing additional regulatory hurdles.
  • Responsive and client-centric approach: Experience a service that prioritizes your needs. Our client focused approach ensures that your questions are answered promptly, and your concerns are addressed with the urgency 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 as well.

Kiwa Medical

Kiwa Medical provides medical devices conformity assessments as a trusted, competent, independent and impartial notified and certification body and accredited testing laboratory to guarantee the continuous supply on the market of consolidated and innovative medical technologies and therapies to patients and healthcare systems, contributing to improve health and quality of life. We are your innovative partner for progress.

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