關於璞旭

About PuHsu

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,協助醫療器材公司完成醫療器材產品上市許可註冊,包含美國FDA、台灣TFDA、歐盟MDR CE認證/IVDR CE認證、加拿大Health Canada等申請服務、品質系統相關的諮詢輔導及教育訓練;另亦提供協助台灣TFDA化粧品許可證申請的服務。

藉由本公司的服務,廠商可建立並有效實施品質管理系統,取得國內外上市核可,利於將產品推進國際市場。

PuHsu Consulting Ltd. provides professional medical device regulatory services in the market registration of medical device, including US FDA, Taiwan FDA, EU MDR CE certification/IVDR CE certification, Health Canada, etc.

We also assists to establish and implement medical device quality management system complying with each countries' medical device market approvals and post-market surveillance to achieve the control of product life cycle.