What are the opening hours?

Monday 08:30 - 17:30 Tuesday 08:30 - 17:30 Wednesday 08:30 - 17:30 Thursday 08:30 - 17:30 Friday 08:30 - 17:30

集賢生技顧問有限公司

Name: 集賢生技顧問有限公司
Address: 蘆洲區集賢路364號3樓, Xinbei, 24747, TW
Telephone: +886282823192

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Taiwan
Xinbei
集賢生技顧問有限公司

集賢生技顧問有限公司為服務全球醫療器材以及體外診斷試劑製造業者，協?

服務項目包括：

台灣食品藥物管理局TFDA產品查驗登記
美國FDA
歐盟CE marking
加拿大Health Canada
日本厚生省(MHLW)
俄羅斯(DOH)等國家上市申請許可

品質系統諮詢(Quality System Compliance Consultant)
醫療器材優良製造規範(GMP, QSD, ISO13485)
醫學檢驗室(ISO 15189, COLA, CAP)
測試實驗室(ISO 17025)

臨床前測試(Preclinical Testing)諮詢
臨床試驗(Clinical Testing)諮詢
技術文件準備(TCF)
上市許可申請(Registration, Premarket Notification, Premarket Approval)的文件準備

IVDD (In Vitro Diagnostic) 體外診斷試劑相關測試
CE IVDR (In Vitro Diagnostic Regulation)
(Performance Study)
CE MDR(Medical Device Regulation) 醫療器材臨床前測試
(Performance Study)
生物相容性測試諮詢
(Biocompatibility): ISO 10993

授權代表(Representative Agent)

Address

蘆洲區集賢路364號3樓
Xinbei
24747

Opening Hours

Monday	08:30 - 17:30
Tuesday	08:30 - 17:30
Wednesday	08:30 - 17:30
Thursday	08:30 - 17:30
Friday	08:30 - 17:30

Telephone

+886282823192

Website

http://www.jensmedical.com/

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