serach

   Honesty•Accuracy

Professionalism•Responsibility

   Honesty•Accuracy

Professionalism•Responsibility

Honesty•Accuracy•Professionalism•Responsibility

Core Value

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

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    Quote and Ordar

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    Timetable Schedule

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    Report Launch

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    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.

【MDR與ISO 13485品質系統之調和與ISO 10993醫材生物相容性實務分享】研討會

麥德凱很榮幸受到領証生醫石紀博士邀請，與領証生醫、北科大生醫材料表面工程產學技術聯盟、虎尾科大生醫植入物數位化加工平台技術聯盟、台灣醫療照護輔具協會及台灣醫材創新書院等單位於2021/01/15共同主辦MDR與ISO 10993研討會。

歐盟MDR改版上線在即，有鑑於醫材同業對於法規更新內容迫切需求，麥德凱與領証生醫攜手共同舉辦研討會，與大家共同分享討論如何因應未來申請歐盟認證上的應變。

 

mdrprogram

mdr 1

[活動花絮]麥德凱生科 洪志駿 總經理 致詞

 

 

mdr 1

[活動花絮]麥德凱生科 劉子瑚 專案經理 分享ISO 10993實務經驗