About
MDG

Medgaea Life Sciences is a third party laboratory that is certificated for OECD GLP, TFDA GLP, ISO 17025 and ISO 9001. Maily based on preclinical CRO, we provide total-soltion services to assist biotechnology industries successfully obtain the product certification and exploit internation market.

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CRO

  • check

    Needs Discuss

  • check

    Quote and Ordar

  • check

    Timetable Schedule

  • check

    Report Launch

  • done

    Case Closed

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Services

With devoting to our core value 『Honesty•Accuracy•Professionalism•Responsibility』,

We have successfully assisted our customers to successfully obtain the product certification in FDA, CE, TFDA and NMPA.

Medical Devices

One of the first priority of medical devices R&D is their safety. The Biocompatibility test is mainly followed the ISO 10993 international standard.

Cell therapy and Regenerative medicine

We assist the safety, effectiveness tests during the R&D process of cell therapy product. All the tests are complied with GLP.

Pharmaceutical development

As the agent of SNBL in Taiwan, will help new drugs company to complete non-clinical trials in medium, large animals and primates in the research and development stage.

Agrochemical and Enviromental Agents

The agroculture products need to review their toxicological data in advance, and all the tests must be carried out in complies with GLP.

Chemical Substances

Providing the toxicological test information!
EPA acquired the test information as the core basis to evaluate the substance announcement.

Health Food/ Ingredients

Provide safety, efficacy and stability tests for food ingredients and health foods.

Registration

Provide registration services.

Pharmaceuticals

Provide batch examine for medicine release, including pyrogen, acute systemic toxicity and other tests.

Laboratory animals and Equipment

An agent and supplier based on research and development of animal experiments, providing import services for various disease model animals in research institutions.


 

MDG 麥德凱生科攜手 CBT 康煜生技參展 Medical Taiwan 2026 展示醫療器材開發一站式整合方案

MDG 麥德凱生科將於 2026 年 6 月 25 日至 27 日參加「2026 台灣國際醫療暨健康照護展(Medical Taiwan 2026)」,並與 CBT 康煜生技共同展出,展示涵蓋生物相容性評估、毒理風險評估、化學表徵分析及醫療器材臨床試驗等完整服務能量,協助客戶加速醫療器材開發與市場准入。

 

醫療器材開發的完整解決方案

 

醫療器材從研發到上市,除了產品功能驗證外,還需面對生物安全性評估、法規要求及臨床驗證等挑戰。

MDG 麥德凱生科長期專注於 ISO 10993 系列標準之生物相容性評估,提供生物風險評估策略規劃、生物相容性試驗、化學表徵分析、毒理風險評估及全球法規支援等服務,協助客戶建立完整且符合國際法規要求的產品安全證據。

同時,透過 CBT 康煜生技於醫療器材臨床試驗領域的專業經驗,進一步提供臨床試驗規劃與執行服務,協助產品完成上市前關鍵驗證。

 

From BEP to BER 一站式整合服務

 

本次展出將重點介紹 MDG 的一站式整合服務模式。

從毒理風險評估(TRA)、試驗規劃(BEP)、試驗執行到最終評估報告(BER),提供完整且具法規符合性的解決方案,協助客戶降低法規風險、縮短開發時程並提升產品上市效率。

 

服務內容包含:

  • ISO 10993 生物相容性評估
  • ISO 10993-17 毒理風險評估(TRA)
  • ISO 10993-18 化學表徵分析
  • Biological Evaluation Plan(BEP)
  • Biological Evaluation Report(BER)
  • 醫療器材臨床試驗服務
  • TFDA、US FDA、CE MDR、NMPA 等全球法規支援

 

 

誠摯邀請蒞臨 D0729

無論您正處於產品開發初期、法規送件準備階段,或規劃臨床試驗與海外市場布局,歡迎蒞臨 D0729 攤位,與 MDG 麥德凱生科及 CBT 康煜生技團隊面對面交流。

我們期待與您共同探討如何透過更完善的評估策略與驗證方案,加速醫療器材成功上市。

MDG 麥德凱生科 × CBT 康煜生技

從生物相容性評估到臨床驗證,一站式加速您的醫療器材上市之路。

 

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展出資訊

展覽地點|台北世貿一館(TWTC Hall 1)

攤位號碼|D0729

展覽日期|2026.06.25(Thu.)– 2026.06.27(Sat.)
https://www.medicaltaiwan.com.tw/zh-tw/index.html 

 

 

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