PuHsu Consulting Ltd. offers comprehensive regulatory services for medical devices, specializing in market registration across various jurisdictions such as the US FDA, Taiwan FDA, EU MDR CE certification/IVDR CE certification, and Health Canada.
Our team of experts is well-versed in the intricacies of the regulatory landscape and can assist you in navigating the complex requirements of each regulatory body. We provide guidance and support throughout the entire process to ensure a smooth and successful market entry for your medical devices.
In addition to market registration, we also provide assistance in establishing and implementing quality management systems tailored to meet the specific requirements of each country. Our services encompass all aspects of medical device quality management, including market approvals and post-market surveillance. By implementing a robust quality management system, you can effectively control the entire lifecycle of your products, ensuring compliance and patient safety.
With PuHsu, you can rely on our expertise and experience to streamline the regulatory process and achieve market approvals efficiently. Contact us today to learn more about how we can assist you in navigating the complex landscape of medical device regulations.