專業醫材認證諮詢

公司介紹

富甲顧問有限公司專注於醫療器材法規與醫療器材 品質系統顧問服務，協助國內外醫療器材廠商順利進入台灣、美國及國際市場。

我們提供 TFDA、FDA、ISO 13485、SaMD 與 AI 醫療器材等專業法規服務，並涵蓋協助客戶申請產品分類判定、查驗登記、QMS 建置、技術文件撰寫及國際法規策略規劃。

我們憑藉豐富的實務經驗與中英文技術文件能力，富甲顧問致力於協助客戶提升法規效率、降低上市風險，加速醫療器材產品成功上市。

Company Profile

Fuchia Consulting Co., Ltd. specializes in medical device regulatory and quality system consulting services, supporting global manufacturers in accessing Taiwan, U.S., and international markets.

Our expertise covers TFDA, FDA, ISO 13485, SaMD, and AI/ML medical device regulations, including product classification, regulatory submissions, QMS implementation, technical documentation, and global regulatory strategies.

With extensive hands-on regulatory experience and strong bilingual technical documentation capabilities, we help clients improve regulatory efficiency, reduce compliance risks, and accelerate successful market entry for medical devices.