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喜訊:美國FDA驗廠順利通過-佛山東方-零483
[2017-01-10]

       佛山東方公司與久順企管是合作多年的好朋友,在接到美國FDA驗廠通知后,佛山市東方醫療對有20年醫療器械專業經驗的久順企管專家團隊充分信任,決定與久順企管攜手合作,共渡艱難的FDA驗廠準備和FDA驗廠審核。久順企管憑借著豐富的FDA驗廠經驗、專業能力和服務水準對佛山市東方醫療進行專業輔導!

       近日,佛山市東方醫療設備廠有限公司零483直通美國FDA驗廠,公司上下歡呼雀躍、到處洋溢喜慶氛圍!

       FDA審核官宣布佛山市東方醫療設備廠有限公司零483零缺陷直通,這是一個振奮人心的消息,久順企管咨詢專家團隊專業和敬業換來了最理想的結果,零483零缺陷直通是小概率事件,足以證明有20年專業經驗的久順企管一直是業界的標桿和龍頭!也足以證明佛山市東方醫療管理層與久順企管合作的決策是正確和英明的!

       佛山市東方醫療設備廠有限公司成立于1990年,從1993年起開始研發電動病床、手動病床、電動輪椅,手動輪椅、助行器等康復、輔助器具產品。經過20年的不斷發展,是在國內外均具有一定影響力的專業康復產品的生產廠家。

       佛山市東方醫療設備廠有限公司為確保產品在市場上能得到客戶更好的認可,提高企業產品的市場份額,高度重視質量控制,先后投入大量的資金在產品檢測設備上。通過推行ERP系統,提升了管理思想,實現了企業內部資源和企業相關的外部資源的整合。規范的管理、有效的制度化與標準化的控制,我司先后獲得了相關的資格證書。1999年成為國內首家獲得歐洲“CE”技術認可的輪椅生產企業,2001年度通過了德國TUV萊茵公司的ISO9001認證,2003年通過德國ISO13485-2003國際醫療器械質量體系認證,同年獲得了美國FDA產品510K注冊,2004年產品所使用的商標被廣東省評為“廣東省著名商標”,同時被佛山市評為“佛山市知名商標”。企業的主導產品在2007年被評選為“中國名牌”產品,同年獲得日本消費品安全協會的產品安全“SG”認證。加上本次美國FDA驗廠零483直通,完美使企業技術、質量提升到國際化水平上。

       久順企管(中國●英國●愛爾蘭),FDA驗廠和醫療器械認證專家:400-658-3933,隨時隨地聆聽您的需求!

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