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

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    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.

麥德凱生科受邀至工研院產業人才訓練課程 分享 醫療器材生物相容性試驗(ISO 10993)實務經驗。

課程時間

109年9月26日(六),上午9:30~下午4:30,共計6小時。

課程介紹

醫療器材生物危害評估是醫療器材產品安全與功效評估重要的課題之一,凡是會與病患或使用者接觸之醫療器材皆需要進行醫療器材生物相容性評估。生物相容性測試的目的就是要確保人體在接觸到材料後,材質不會釋放有毒物質,造成局部或全身性細胞毒性、致癌性及生殖毒性,人體在接觸到材料後不會引起發炎反應、免疫反應、毒性反應、血栓形成反應等危害。
    國際上對於醫療器材生物相容性之評估主要參考依據為ISO10993-1:2018,新版將原本舊版醫療器材生物相容性的測試由原來的採用依接觸時間與接觸位置的評估模式,轉變為基於風險管理評估方式進行相關評估與最終生物測試。
    衛福部 TFDA 參照廣為國際衛生主管機關、學界和業界所使用的 ISO 10993 系列為規範標準,而醫療器材管理辦法主要參考美國 FDA,將醫療器材依據風險程度,分成三種等級。第三等級(高風險性)和部分的第二等級(中風險性)產品上市前需執行臨床前試驗,需要提供相關資料暨文獻,例如由符合優良實驗室操作規範 (GLP) 的實驗室提供臨床前試驗結果報告及非臨床安全性評估(生物相容性)以證明產品之安全性及品質。
    本課程透過生物相容性專業知識與實務經驗分享,幫助學員掌握ISO 10993的基本架構,以及建立產品生物相容性風險分析評估的最適切方案,提升醫材產品品質,降低驗證成本與時間,以提升產品上市後效益。

課程特色/目標

建構學員對醫療器材生物相容性試驗(ISO 10993)有基本概念及實務應用能力。

課程對象

醫療器材產業之研發、法規、品保等從業人員,以及有志投入醫療器材產業之相關人員。

講師簡介

劉子瑚 老師
現任:麥德凱生科股份有限公司 專案經理
經歷:大專院校育成通識生物相容性課程授課講師、協助台灣醫材廠商在台灣TFDA、美國FDA、歐盟CE順利取證
專長:生物相容性評估及實務經驗

課程大綱

一、生物相容性試驗簡介
二、ISO 10993生物相容性標準規範
三、ISO 10993風險評估程序
四、選擇生物評估方法與執行重點
五、常見醫療器材相容性案例討論與經驗分享