DQS MED has been appointed by the Central Authority of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) for procedures based on the EU Medical Devices Regulation VO (EU) 2017/745 (MDR). With the anticipated publication in the NANDO database (MDR Article 42 (11) and (12)) in the coming weeks, DQS MED will officially start our activities as a Notified Body for MDR, on the basis of many years’ experience for MDD.

Of the 46 Notified Bodies that currently applied for designation under the MDR, only 40 had a branch audit by the competent national and European authorities and only 25 Notified Bodies subsequently submitted a CAPA plan. It can therefore be assumed that by the end of the transition period on 25 May 2021, significantly fewer Notified Bodies than today will be able to offer their services against MDR.

DQS Med will continue to be a reliable and competent partner for our clients in the field of medical device CE Marking approvals.

DQS Service

DQS is a certified body for ISO 9001:2015, ISO 13485:2016 and MDSAP. DQS is also an authorized notified body for CE marking under EU MDD and MDR.

DQS Academy provides training courses of internal auditors and lead internal auditors for ISO 9001 and ISO 13485, to equip the clients with the knowledge to implement an effective medical QMS in the organization.

 

DQS MED已得到德國ZLG批准可依據歐盟”醫療器械法規” (MDR) 對醫療設備實施CE認證。預期在幾周內被錄入NANDO資料庫後,DQS MED 到時正式開始作爲“公告機構”提供基於MDR的醫療器械審批服務。這是在多年的基於MDD的醫療器械審批服務經驗的基礎上的進一步擴展。

在目前所有46家申請MDR通告組織資質的公司中,只有40家得到了有關國家或歐洲監管機構的審核,其中又只有25家在審核後提交了糾正和預防措施。所以,可以預計,在目前的過渡期於2021年5月25日截止後,市場上可根據MDR進行CE認證的通告組織數量將會顯著減少。

DQS MED將繼續在醫療設備的CE認證領域保持作爲我們客戶可信賴的合作夥伴。

DQS服務

DQS是ISO 9001:2015ISO 13485:2016認證機構、歐盟醫療器械CE標誌審批的公告機構、以及提供多國 醫療器械單一審核方案 (MDSAP) 的審核組織。
DQS學堂 提供ISO 9001和ISO 13485 內審員培訓主任審核員培訓課程,以幫助客戶獲得醫療設備質量管理體系(QMS)實施所需的知識。
歡迎聯繫我們以獲取所需的服務。