關於璞旭

璞旭顧問有限公司致力於提供專業的醫療器材法規服務及相關證照代辦服務，我們協助醫療器材公司完成醫療器材產品的上市許可註冊，涵蓋美國FDA、台灣TFDA、歐盟MDR CE認證/IVDR CE認證、加拿大Health Canada等多個地區的申請服務。我們擁有豐富的經驗和專業知識，能夠協助您順利通過各個主管機關的要求，確保醫療器材順利進入市場。

除了產品上市許可註冊外，我們還提供品質系統相關的諮詢輔導及教育訓練，我們的服務涵蓋醫療器材的品質管理系統建立和實施，以符合各國家的特定要求。我們協助您在產品的整個生命週期中實施健全的品質管理體系，確保產品符合法規要求，同時保障患者的安全。

透過璞旭的專業知識和豐富經驗，您可以放心地將法規程序納入產品生命週期，高效地取得產品的上市核可。請立即聯繫我們，了解更多如何在醫療器材法規要求中獲得支援，並順利進入國際市場。

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.