Improvement actions: New webpages and integration into the Kiwa website, Technical File template & Project numbering
Officially, the launch is in January, but we are already live with our new webpage! On the webpage you will find information on our impartiality, services and of course all client specific information: our information package, notification of changes forms and what to do in case of a vigilance case. Coming year, we will extend our new webpage with additional in-depth topics to support your certification process. The old website will phase out in 2026. We keep you informed!
New Technical File Template
In 2025, we introduced a redesigned Technical File template to keep pace with our growing team and evolving regulatory requirements (MDR and competent authorities). After five years, this update was essential to enhance clarity and meet the increasing demand for detailed documentation, all without extending review timelines.
We’ve successfully completed our first projects using the new template. While there were minor challenges, the overall improvements have been well received by our team. Starting in January, we will gather feedback from customers to further refine the template.
Transition to new Project Numbering
Following our legal merger in May 2025, we implemented a new project numbering system. All new projects now begin with Pxxxxxx, and the previous format (e.g., 25M000xxx) will be fully phased out by January 1, 2026.
This change will apply across all reports, communications, and invoices. Please note: there is no impact on our services, and this update is purely administrative and designed for consistency.
Thank you for your continued trust and collaboration. These changes are designed to improve efficiency and compliance while ensuring a seamless experience for you. If you have any questions or feedback, please don’t hesitate to reach out—we value your input.
Kiwa Medical Device Certification
Medical devices placed on the European market must comply with the Medical Device Regulation (EU) 2017/745 (MDR). This regulation ensures that devices meet high standards of safety and performance.
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