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 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。