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  • View More Class III Medical Device Certificates issued by TFDA _ Collagen Hemostatic Dressing.jpg
    News

    Master Laboratory Co., Ltd.'s Long-Term Client Has Receives Three Class III Medical Device Certificates from Taiwan's Ministry of Health and Welfare on April 12th

    Master Laboratory Co., Ltd.'s long-term client, ACRO Biomedical Co., Ltd., has received three Class III Medical Device Certificates issued by Taiwan’s Ministry of Health and Welfare on April 12th. Achieving three Class III certifications in a single day marks a significant milestone in the company's development. The certified products include Collagen Hemostatic Dressing, Decellularized Dermis Hemostatic Microspheres, and Decellularized Dermis Hemostatic Gel.

    These certifications validate the safety and efficacy of ACRO Biomedical Co., Ltd.'s innovative hemostatic solutions. They were made possible through the required evaluations and studies conducted in collaboration with Master Laboratory. We are proud to have supported ACRO Biomedical Co., Ltd. throughout the certification process and are honored to have contributed to this remarkable achievement.

    瑞德生技長期客戶 亞果生醫 4/12日收到三張衛福部核准的三類醫材證書。膠原蛋白止血敷料,去細胞真皮止血微粒,去細胞真皮止血凝膠。一天取三張三類醫材證書,這應該是史無前例!實驗都是委託瑞德執行的!





    膠原蛋白止血敷料 
    Collagen Hemostatic Dressing 







    去細胞真皮止血微粒
    Decellularized Dermis Hemostatic Microspheres     







    去細胞真皮止血凝膠
    Decellularized Dermis Hemostatic Gel                                         





                                                                                           
                                                                                                                       
                                                     




     



     

     
  • View More 瑞德生技榮獲2021國家新創獎-2.jpg
    News

    Master Laboratory Co., Ltd. has been honored with the National Innovation Award

    Master Laboratory Co., Ltd. was awarded the National Innovation Award in recognition of its outstanding innovation and excellence in medical device testing.



        









     
  • View More FDA 510_k_ Clearance Achieved for Resorbable Calcium Salt Bone Void Filler Device.jpg
    News

    Master Laboratory Co., Ltd.’s Testing Reports Support Client: FDA 510(k) Clearance Achieved for Resorbable Calcium Salt Bone Void Filler Device

    Master Laboratory is pleased to announce that our testing reports have played a key role in helping a client secure FDA 510(k) clearance for their Resorbable Calcium Salt Bone Void Filler Device. The comprehensive testing data provided by Master Laboratory were crucial in meeting the regulatory requirements, ensuring the device’s safety and effectiveness for market approval.













     
  • View More MDR之臨床評估報告實務分享-3.jpg
    News

    Master Laboratory Co., Ltd. Co-Hosts MDR Clinical Evaluation Workshop

    Master Laboratory Co., Ltd. jointly hosted a workshop on MDR clinical evaluation reports, sharing valuable insights and practical guidance with industry professionals.



    台灣醫材創新書院、北科大生醫材料表面工程產學技術聯盟、虎尾科技大生醫植入物數位化加工平台技術聯盟、台灣生技醫療照護輔具協會、 中華民國醫療器材商業同業公會全國聯合會、金屬工業研究發展中心、瑞德生技股份有限公司、領証生醫 共同主辦於2021年4月8日 在北投會館 (台北捷運復興崗站) 開辦 MDR之臨床評估報告實務分享,上課時數6小時,9:00~9:30 期間報到。

           




     

     
  • View More 暨醫療器材生物相容性評估及試驗案例分享課程-1.jpg
    News

    Master Laboratory Co., Ltd. Shares Expertise at TFDA Training

    Master Laboratory Co., Ltd. was honored to be invited by the Taiwan Food and Drug Administration (TFDA) to contribute its expertise to the “Comprehensive Professional Review Training Program for Medical Devices” in conjunction with the “Medical Device Biocompatibility Assessment and Case Study Sharing.”

    Our team shared practical experience and real-world case studies, providing industry professionals actionable insights on biocompatibility testing and evaluation to support medical device safety, quality, and regulatory compliance.


     

    110 年 03 月 26 日(星期五) 09:10 ~ 16:30 於衛生福利部食品藥物管理署 舉行「醫療器材全方位專業審查訓練計畫」暨「醫療器材生物相容性評估及試驗案例分享」,誠摯邀請瑞德生物科技股份公司各位業界先來臺授課。

               



     



     
  • View More 瑞德生技榮獲疾管署_CDC_實驗室風險管理系統-精進獎-1.jpg
    News

    Master Laboratory Co., Ltd. Awarded the CDC’s Excellence Award for Laboratory Risk Management System

    Master Laboratory Co., Ltd. is proud to announce that it has been awarded the Laboratory Risk Management System — Excellence Award by the Taiwan Centers for Disease Control (CDC). This prestigious award recognizes our continuous commitment to laboratory safety, risk management, and high-quality testing.

    For years, Master Laboratory has provided reliable, safe, and accurate testing services. Through our rigorous laboratory risk management system, we ensure that every test meets the highest standards of quality and safety.

    Receiving the CDC Excellence Award further reinforces Master Laboratory’s position as a leader in the medical and biotechnology sectors, while inspiring us to continue innovating and advancing laboratory safety and testing quality.

     


    瑞德生技榮獲疾管署(CDC)實驗室風險管理系統—精進獎






     
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    News

    Master Laboratory Conducts PRP Injection Study in ACLT/OA Animal Model for Cartilage Repair

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    News

    Master Laboratory Successfully Completes Corneal Efficacy Study for a Medical Device

  • View More 2015.12.9 瑞德與南科管理局簽定合作備忘錄-1.jpg
    News

    Master Laboratory Co., Ltd. Signed MOU with the Southern Taiwan Science Park Bureau to Strengthen Biotech Collaboration

    On December 6th, the Southern Taiwan Science Park Bureau hosted the “Dental Experience Center Technology Exchange and Matchmaking Event” at Kaohsiung Medical University to support the dental device industry in introducing their products to both domestic and international healthcare markets. The event successfully connected dentists with dental manufacturers, fostering collaboration and knowledge exchange.

    The Bureau also invited two Contract Research Organizations (CROs), Master Laboratory Co., Ltd. and SEQPRO, Inc., to assist manufacturers with clinical trial planning and to connect them with trial institutions. This collaboration enables companies to conduct trials more efficiently and provide clinical data to dentists, thereby enhancing product reliability.

    Through this comprehensive support, manufacturers gain better access to medical institutions and are able to expand their market reach, strengthening the overall ecosystem for dental devices in Southern Taiwan Science Park.



    (工商時報)

    參與牙科體驗中心技術交流媒合會貴賓合影;前排左起為瑞德副總經理謝銘峰、南科管理局局長林威呈、信益普董事長陳錦豐。後排左起為金屬中心董事長蔡明祺、科技部次長錢宗良、台灣口腔暨醫材發展促進協會理事長林俊彬、高醫大校長劉景寬。圖文/葉圳轍


    為協助南科牙科醫材產業聚落廠商產品打入國內外醫療體系,科技部南科管理局特於6日在高雄醫學大學舉辦「牙科體驗中心技術交流媒合會」,成功鏈結牙醫
    師與牙科廠商媒合平台,場面熱絡。

    據了解,隨著人口高齡化,近幾年國內植牙市場蓬勃發展,除了吸引許多精密機械大廠轉進人工植牙領域外,在南科管理局積極推動下,牙科醫材產業聚落也在南部逐漸成型;該聚落廠商已完成產品開發並取得相關販售許可,接下來就是要伺機打入國內外醫療體系。



    有鑑於此,科技部南科管理局特於周日(6日)在高醫大舉辦「牙科體驗中心技術交流媒合會」,邀請ABC牙醫聯盟謝尚廷院長、高雄醫學大學牙科部何坤炎部長與維新管理顧問公司劉南佑總經理等臨床牙醫師進行演講,介紹目前台灣牙醫界關鍵領袖對MIT牙科產業分析、植牙系統的期待、數位牙科的期待及其相關醫材技術及臨床需求缺口的未來發展。

    會中,也特別邀請北、中、南知名牙醫師與會,讓聚落廠商產品有機會介紹給與會牙醫師,以促使未來與各大醫院及醫療院所合作機會。

    此外,為使增加產品信賴度,南科管理局更邀請兩家CRO公司與廠商媒合,提供醫療器材臨床試驗規畫與臨床試驗機構媒合,讓與會的廠商能更快速完成臨床試驗,並將臨床數據提供給醫師參考,增加產品信賴度,透過本次整體一條龍的服務,可有效協助廠商打入醫療院所,增加國產品的市占率。

    該媒合會執行單位金屬中心表示,該活動吸引國內醫療器材廠商約100位專業人士與20家南科牙科醫材廠商,成功媒合產學合作關係,預期將為我醫材業者打造優質的一條龍媒合交流平台。




     
  • View More 2015 瑞德生技進駐竹北生醫園區 擴大服務生醫客戶_竹北市生醫路二段2號_-1.jpg
    News

    Master Laboratory Co., Ltd. Moves into Hsinchu Biomedical Science Park to Expand Services for Biomedical Clients

    Master Laboratory Co., Ltd. has moved into the Hsinchu Biomedical Science Park, located at No. 2, Section 2, Shengyi Rd, Zhubei City, Taiwan.

    As a company specializing in professional laboratory testing, this relocation allows us to enhance our capabilities, accelerate research, and provide more comprehensive solutions for clients in the biomedical and life sciences sectors. By situating ourselves within Taiwan’s growing biomedical hub, we aim to strengthen collaboration and better support the biotech industry’s innovation needs.

    This expansion reflects our ongoing commitment to delivering precise, high-quality, and reliable testing services to our clients and partners. It also reinforces Master Laboratory as a trusted partner in the biotechnology field, dedicated to supporting scientific advancement and industry innovation.
  • View More 2014.12.30 塑膠中心與瑞德生技簽訂醫療器材檢測聯盟。生物相容性實驗室啟用,醫材檢測大邁進。-1.jpg
    News

    Plastics Industry Development Center (PIDC) Forms Medical Device Testing Alliance with Master Laboratory Co., Ltd. and Taiwan Advanced Sterilization Technology, Inc., and Inaugurates Medical Device Biocompatibility Laboratory

    The Plastics Industry Development Center (PIDC) held the inauguration ceremony for its Medical Device Biocompatibility Laboratory on December 30. During the event, PIDC signed a Medical Device Testing Service Alliance agreement with Master Laboratory Co., Ltd. and Taiwan Advanced Sterilization Technology Co., Ltd.

    Through this alliance, medical device manufacturers will have access to comprehensive end-to-end services covering regulatory compliance, product development, design, packaging, sterilization validation, testing and verification, and market launch. This integrated approach provides full lifecycle assistance for medical device development, strengthening Taiwan’s medical device ecosystem and marking a new milestone for the industry.


    2014-12-30 經濟日報 楊聰橋

    塑膠中心12月30日舉行「醫療器材生物相容性實驗室」落成及「醫療器材檢測服務聯盟」成立儀式,工業局科長郭肇中、食藥署副組長周秀冠、醫健會副理事長方旭偉、台中市醫材公會理事長何英獎及台中榮總院長李三剛等貴賓應邀出席。
     


    台中市醫材公會理事長何英獎(左起)、醫健會副理事長方旭偉、台中榮總院長李三剛、工業局科長郭肇中、食藥署副組長周秀冠及塑膠中心總經理林志清等貴賓應邀出席實驗室剪綵啟用儀式。 楊聰橋/攝影
     
          
     
    工業局科長郭肇中肯定塑膠中心執行業者商業化量產最後一哩路的努力與貢獻,並期望實驗室與聯盟的成立,帶領塑膠業者轉型、升級,再創產業另一高峰。郭肇中指出,醫療器材超過50%與高分子材料組件有關,我國塑膠產業擁有優勢材料及精密製造技術能力,若能轉換在製程管控嚴謹的醫療器材產品上成為競爭利基,預期將可創造另一波產業成長動能。

    塑膠中心總經理林志清表示,塑膠中心長期致力高分子醫療器材的研發、檢測、驗證、輔導與審查,另也持續整合國內各大醫學中心,以創新及實用的思維開發各式醫療器材,協助各醫療器材業者執行臨床前的試驗服務,服務醫療器材廠商數超過150家。未來中心會大幅提高投入醫療器材服務的比重,除建構生物相容性實驗室,並將投入大筆預算興建醫療器材大樓。

    林志清說,生物相容性實驗室啟用後,塑膠中心將結合原有的微生物滅菌實驗室、醫材包裝袋強力實驗設備,以及功能性實驗設備等服務能量,提供檢測服務的產品範圍可自Class 1的低風險性醫療器材,到Class 3的高風險性醫療器材,藉由提供各種醫療產品完整的檢測,滿足國內醫療器材廠商的驗證需求。

    此外,塑膠中心、艾思特科技及瑞德生物科技,也在30日簽訂「醫療器材檢測服務聯盟」,透過聯盟的成立,使塑膠中心在醫療器材的服務能量更完整,讓醫材業者可獲得自系統法規、產品開發、設計、包裝、滅菌確效、檢測驗證到上市銷售的「一條龍」式服務,有助加速業者創新研發,促進我國醫療器材產業的發展。



     
  • View More 瑞德生技 生技醫療產品檢測專家.jpg
    News

    Master Laboratory Co., Ltd. — Expert in Biotechnology and Medical Product Testing

    Master Laboratory Co., Ltd. — Expert in Biotechnology and Medical Product Testing


    瑞德生物科技 — 生技醫療產品檢測專家