Product Certification

Integration of the full process of technical document preparation and registration application: 1. Assist in preparing compliance technical documents such as CE MDR/IVDR, FDA 510(k), etc.; 2. Act as an agent to submit registration applications, conduct professional communication with official authorities, and efficiently promote the review progress.

Diversified certification issuing channels: We have established long-term cooperation with multiple globally authoritative notified bodies (NB) and compliance service institutions, covering mainstream markets including EU MDR/IVDR, US FDA, Russian RZN, EAEU, Southeast Asia, Middle East and other major markets. With mature certification issuing and registration channel resources, we can efficiently promote the compliance process of various medical devices and ensure smooth certificate issuance; Full coverage of medical device products: Relying on WANVE's local compliance teams in multiple regions around the world, our local overseas experts can track and conduct in-depth analysis of new export regulation updates in real time. For all categories of medical devices including active, passive and IVD products, we collaborate with domestic experts to provide customized export compliance solutions for products ranging from low-risk to high-risk; Refined whole-process management and control: We provide refined whole-process management and control services, covering project negotiation, solution formulation, test coordination, technical document preparation, registration application, to certificate verification and subsequent maintenance, realizing closed-loop management of the entire service chain. We regularly synchronize progress during the certification process, respond quickly to various issues, continue to track regulatory updates after certificate issuance, and provide supporting services such as annual audit and change maintenance to comprehensively ensure the continuous compliance of your products; Efficient and accurate localized service: We have physical operating entities in core markets including the EU, Russia, Vietnam, Brazil, Saudi Arabia and other regions. We are familiar with the registration requirements and practical operation details of local competent authorities, can provide authorized representative services for multiple regions, greatly shorten the project cycle and improve the registration success rate.