QMD SERVICES GMBH Services GmbH 成立于2018 年 12 月，为Quality Austria – Trainings, Zertifizierungs und Begutachtungs GmbH 的子公司，总部位于维也纳和林茨。自成立以来，公司始终专注于医疗器械和 IVD 的合格评定服务。
2022 年 12 月 23 日，QMD SERVICES GMBH 迎来重大突破：被正式指定为 奥地利唯一获欧盟体外诊断医疗器械法规（IVDR）认可的公告机构，编号NB 2962。
2024 年 5 月 14 日，在经过充分准备并获得政府批准后，QMD SERVICES GMBH 又被指定为 奥地利唯一获欧盟医疗器械法规（MDR）认可的公告机构。
由此，QMD SERVICES GMBH 在奥地利占据了独特地位，并成为全欧盟仅有的 17 家同时具备 MDR 与 IVDR 指定资格的机构之一。作为其中最年轻的成员，QMD SERVICES GMBH 以其灵活性和现代化方式脱颖而出。
上海amjs澳金沙门作为 QMD Services（NB2962）的中国官方合作伙伴，亦提供 MDR与IVDR相关认证服务，助力中国医疗器械企业进入欧盟市场。
About QMD Services GmbH
QMD SERVICES GMBH Services GmbHwas founded in December 2018 as a subsidiary of Quality Austria – Trainings, Zertifizierungs und Begutachtungs GmbH, with headquarters in Vienna and Linz. Since its creation, the company has specialized in conformity assessment for medical devices and IVDs.
On December 23, 2022, QMD SERVICES GMBH reached a significant milestone: it became Austria’s only notified body designated under the EU In Vitro Diagnostic Regulation (IVDR), with the identification number NB 2962.
On May 14, 2024, following extensive preparation and government approval, QMD SERVICES GMBH was also designated under the EU Medical Device Regulation (MDR).
This achievement gives QMD SERVICES GMBH a unique position within Austria and places it among only 17 organizations across the European Union with dual MDR and IVDR designation. It is also the youngest member of this select group, distinguished by its agility and modern approach.
As the official China partner of QMD Services (NB 2962), Shanghai amjs澳金沙门 also provides MDR and IVDR certification-related services to support Chinese medical device manufacturers in entering the EU market.
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