News Clipping, SCOOP, May, 09
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VINCENT MEDICAL (DONG GUAN) MANUFACTURING CO LTD AWARDED
ISO 14971:2007

Vincent Medical (Dong Guan) Manufacturing Co Ltd, which is a globalized medical device manufacturing company established in 1988, strives to provide high quality, affordable priced respiratory medical devices to their clients. Vincent Medical is also proactive in risk management to create the greatest wellness to their patients. Her commitment has been proven by ISO 14971:2007 Medical Devices – Application of Risk Management to Medical Devices Certification awarded by SGS Hong Kong Ltd on 26th Mar, 2009.

ISO 14971 certification award is not only the milestone for Vincent Medical, but also the landmark for SGS Hong Kong Ltd in ISO 14971 certification to the first qualified company. Vincent Medical can make judgments relating to safety of a medical device, including the analyzing, evaluating, controlling and monitoring of risks, taking into account the generally accepted state of the art, in order to determine the probable suitability of a medical device to be placed on the market for its intended use/intended purpose; identify hazards associated with a medical device, estimate and evaluate the risks associated with those hazards, control those risks, and monitor the effectiveness of that control.

ISO 14971 helps demonstrate an established system to eliminate, reduce and manage risks to manufacturers’ medical devices introduced through design, manufacture and use. In addition, manufacturers can utilize both used production and post production information to further improve device safety.

SGS Hong Kong was founded in 1959 as the pioneer in quality services.  With over 50 years local experience, SGS is now equipped with a strong team of 1000 committed professionals in multi-disciplines. As the leader in one-stop total quality services, SGS Hong Kong offers high-level expertise in testing, verification, technical consultancy and inspection of products from various industries. Our professionals also contribute to the enhancement of clients’ management standards through training and certification. With its high standard of services, SGS serves commercial clients, governments and international institutions.

 

東莞永勝醫療制品有限公司榮獲ISO 14971:2007 國際認證

東莞永勝醫療制品有限公司於1988年成立並發展成一家國際醫療器械製造商,當中更致力供應高質素、能負擔之呼吸醫療器械給客戶。永勝醫療亦主動進行風險管理並對病人創造最大的健康治療。香港通用公証行有限公司的於2009年3月26日頒發「ISO 14971:2007醫療器械生產企業風險管理」認証予永勝醫療,足以証明她對客戶及病人之承諾。

獲取ISO 14971認証不僅是永勝醫療的里程碑,亦是對香港通用公證行向第一家通過審核合格之公司頒發認証的重要時刻。永勝醫療能針對醫療器械的安全性做出一些判斷 -- 包括對風險之分析、評估、控制和監測-- 以便確定將醫療器械投放市場用於預定用途或預期目的是否可能適合;判定和醫療器械有關的危害,評估與這些危害有關的風險,控制這些風險並監督控制的有效性。

ISO 14971能證明製造商擁有一個完備的體系可以排除,減少和控制醫療產品在設計製造和使用過程中產生的風險。 另外亦能證明製造商對產品品質和安全性進行產後監測。

香港通用公證行創立於1959年,一直擔當著品質服務的先鋒,擁有逾50年的本地專業經驗及1100多名訓練有素的專家。作為 「一站式」 品質服務的領導者,香港通用公證行致力為不同行業的產品提供卓越的測試、驗證、技術顧問及檢驗服務。此外,透過培訓及認證的專業服務,亦協助不少客戶提升其管理水平。香港通用公證行服務對象廣泛,客戶包括商業客戶、政府部門及國際機構等。