发布者:奥世认证  发布时间:2024-06-24  浏览次数:




图片:QMD首席执行官Ing. Florian Heffeter,EUR ING(FEANI),学士,法学硕士,和Dr. Anni Koubek © Jana Madzigon


首个体外诊断证书(IVDR)在创纪录的九个多月内获得:在QMD服务,事情进展迅速。总部位于维也纳和林茨的Quality Austria - 培训,认证和评估有限公司的子公司自2022年12月底以来一直作为体外诊断的公告机构(例如血液或尿液样本的实验室测试,血糖测试,PCR测试等)运营,现在于2024年5月27日向土耳其公司Anatolia Geneworks签发了首个证书。此外,在5月14日,QMD服务已被指定为医疗器械的公告机构,现在是欧洲仅有的十一家公司之一,涵盖两项法规。仅三周内,唯一的奥地利认证机构收到了来自八个欧洲国家的合格评估询问。

“认证通常需要12到18个月,”QMD服务的首席执行官Florian Heffeter说。 “我们自豪的是,我们的团队 - 在所有的关心和最高质量下 - 在短短九个多月内完成了这一任务。这是QMD服务作为整个欧洲公告机构的最佳广告,国际兴趣证实了这一点。”

“Anatolia通过获得其首个欧盟质量管理体系证书达到了一个重要的里程碑。这一成就突显了Anatolia在分子诊断领域保持最高标准的承诺,”Anatolia Geneworks副总裁Dr. Elif Akyuz说。

QMD服务向Anatolia Geneworks签发的首个IVDR证书涵盖用于检测传染剂(包括性传播病原体)的存在或暴露的设备。

血液或尿液样本的实验室测试,血糖测试,X射线设备,心脏起搏器,人工假体 - 体外诊断和医疗器械是现代医疗保健的一个组成部分,市场因此蓬勃发展。医院和医疗设施中使用了750,000种医疗器械。系统面临的一个特殊挑战是:业由于行的高创新水平,产品每18到24个月就会被新的改进产品所取代。因此,公告机构的长等待时间可能会延迟上市。

“通过QMD服务,奥地利现在再次拥有一个IVDR和MDR认证机构,这对于该领域的数百家本土公司来说是一个巨大的优势。巨大的国际兴趣也表明了对公告机构的普遍需求,”Florian Heffeter说。


18. Jun 2024

IVDR certificate for test kits for the identification of infectious diseases

QMD Services: First in-vitro diagnostics certificate achieved in record time

Certificate issued within just nine months; further success: requests for medical device certification from eight countries after just three weeks


The first in-vitro diagnostics certificate (IVDR) was achieved in a record time of just over nine months: At QMD Services, things are progressing rapidly. The subsidiary of Quality Austria - Trainings, Zertifizierungs und Begutachtungs GmbH, which is based in Vienna and Linz, has been operating as Notified Body for in-vitro diagnostics (such as laboratory tests for blood or urine samples, blood glucose tests, PCR tests, etc.) since the end of December 2022 and now issued the first certificate for the Turkish company Anatolia Geneworks on May 27th, 2024. In addition, on May 14th, QMD Services has been designated as Notified Body for medical devices and is now one of only eleven companies in Europe covering both regulations. In just three weeks, the only Austrian certification body received conformity assessment inquiries from eight European countries.

“Certification normally takes 12 to 18 months,” says Florian Heffeter, CEO of QMD Services. "We are proud that our team - with all the care and the highest quality - managed to complete this in just over nine months. This is the best advertisement for QMD Services as a Notfied Body for the whole of Europe, and the international interest confirms this."

“Anatolia has achieved a significant milestone by obtaining its first EU Quality Management System certificate. This achievement underscores Anatolia's commitment to maintaining the highest standards in molecular diagnostics,” says Dr. Elif Akyuz, Vice President of Anatolia Geneworks.

First IVDR certificate for PCR kits for the identification of infectious diseases

The first IVDR certificate issued by QMD Services to Anatolia Geneworks covers devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents.

Booming market: QMD Services shortens “time to market”

Laboratory tests for blood or urine samples, blood glucose tests, X-ray devices, pacemakers, artificial prostheses - IVDs and medical devices are an integral part of modern healthcare and the market is booming accordingly. There are 750,000 medical devices in use in hospitals and health facilities. The system faces a particular challenge: due to the industry's high level of innovation, products are replaced by new, improved ones every 18 to 24 months. Long waiting times at notified bodies can therefore delay market entry.

"With QMD Services, Austria now again has a certification body for IVDR and MDR, which is a huge advantage for hundreds of domestic companies in this sector. The great international interest also demonstrates the need for notified bodies in general,” says Florian Heffeter.


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