Project Description

ISO 13485 Medical Devices QMS Certification | 醫療器械品質管理體系認證

The rapid development of the DQS competence center for medical devices continued in 2008. By now more than 1,200 customers have been certified by DQS according to the various standards of this business sector; and with its excellent service DQS continues to support them anywhere in the world. This growth is also a result of increasing international requirements. Therefore we will support you while entering new worldwide markets for manufacturers of medical devices.

The increasing internationalization is both for us and our customers challenge and great opportunity at the same time. These are the services that we already offer to our customers worldwide.

ISO 13485:2016 is released by ISO to replace ISO 13485:2003. The new standard has taken in account the medical devices related regulations in primary markets, which will facilitate the implementation of MDSAP in the world.

ISO 13485是全世界醫療設備行業最廣泛接受的品質系統,並迅速成為進入此行業供應鏈的通行證之一。此標準是依照 ISO 9001基礎框架,另外根據醫療設備行業特點增加相關特別要求。ISO 13485 對產品設計、開發、採購、生產、運输、安裝和服務等過程制定全面的要求,並強調產品相關風險的管理。遵循此標準的醫療設備製造商表示其已建立品質保證體系以保障公眾的安全,實施 ISO 13485 亦可增加公司的信譽,贏得客戶、醫療工作者和終端使用戶的信任。

不少發達國家都強制或推薦醫療設備產品生產者符合 ISO 13485 或類似體系標準的要求。相應地,多數大型醫療設備產品製造商都對供應商提出了 ISO 13485 的第三方認證要求。

國際標準化組織發佈了用來代替ISO 13485:2003 的ISO 13485:2016。此標準考慮了多個主要市場的醫療設備相關法規,可以促進醫療設備單一審核方案在全球的實施。

Related Training Courses | 相關培訓課程

The courses include ISO 13485 Internal Auditor, Standard Understanding, ISO 14971 Understanding, etc.
課程包括ISO 13485內審員、標準理解、ISO 14971理解、等。

Related Important Posts | 相關重要發佈

[2016.03.10] Release of ISO 13485:2016 新版標準

[2017.03.02] MDSAP for Medical Devices

[2017.03.06] MDR & IVDR for Medical Devices to EU

Benefits | 益處

  • Comply to statutory and regulatory requirements 符合法律法規的要求
  • Risk Management 管理風險
  • Prevent errors instead of correcting them 以預防錯誤的觀念取代修正錯誤的想法
  • Enchance customer trust and satisfaction 贏得客戶信賴
  • Save time and operating costs 節省成本與時間

Why DQS? | 為什麼選擇 DQS?

  • DQS is a Notified Body recognized by EU to provide CE Marking and product approval service for medical devices
    DQS 是歐盟認可的少數授權公告組織之一,可以爲醫療設備提供 CE 標誌和上市批准服務
  • DQS is one of the few Audit Organizations (A.O.) to provide MDSAP service
    DQS 是少數可以提供醫療設備單一審核方案服務的認證機構之一


Related News 相關新聞:

MDSAP for Medical Devices to Canada

September 1st, 2018|Comments Off on MDSAP for Medical Devices to Canada

In December 2015, Health Canada announced the transition from CMDCAS (Canadian Medical Devices Conformity Assessment System) to MDSAP for organizations to obtain/maintain Canadian Medical Device Licenses for [...]

DQS Compact 81 – Customer Journal – II/2017

August 8th, 2017|Comments Off on DQS Compact 81 – Customer Journal – II/2017

DQS Compact 81 Customer Journal to clients from DQS. Please refer to below letter for details. Be the first to know, subscribe DQS Newsletter. [...]

MDR & IVDR for medical devices to EU

March 6th, 2017|Comments Off on MDR & IVDR for medical devices to EU

Updated on Jul 10, 2018 MDR & IVDR - The final text of the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical [...]

MDSAP for Medical Devices

March 2nd, 2017|Comments Off on MDSAP for Medical Devices

Medical Device Single Audit Program Under the Medical Device Single Audit Program (MDSAP), the medical device manufacturers can let a recognized auditing body [...]