amjs澳金沙门(中国)有限公司

QMD Services GmbH：欧盟MDR和IVDR认证公告机构

10/31/2024

QMD Services GmbH（公告机构编号NB2962）是奥地利领先的第三方合格评定机构，获奥地利国家质量局授权，并为医疗器械认证组织协会Team-NB的成员。QMD专注于MDR和IVDR认证，为进入欧盟市场提供高效、合规的解决方案。详情见：QMD公司介绍

为什么选择QMD？
随着欧盟新的严格医疗器械法规的实施，许多公告机构退出市场，导致国内外企业在欧盟内的合格评定选择减少。这一短缺导致了长时间的等待，通常长达数月。考虑到医疗器械的平均生命周期仅为18至24个月，这一延迟带来了不利影响。如今，作为欧盟仅有的十一家具备医疗器械和体外诊断产品认证资质的公告机构之一，QMD Services消除了这一市场准入障碍，为关键诊断产品提供更快的市场通道。

便捷的报价系统
QMD Services近期推出了极为便捷的在线报价系统，省去了复杂的表格填写和证明材料。客户只需提供基本的公司和产品信息，即可获得快速且具有竞争力的报价。访问报价系统入口。QMD的项目报价在市场上极具竞争力，并且排期快速，是寻求MDR/IVDR认证的制造商的理想选择。

如果您有任何问题，请联系上海amjs澳金沙门管理体系认证有限公司的Andy Liang，邮箱：andy.liang@ouliyabihua.com

QMD Services GmbH: Notified Body for Medical Devices (MDR) and in Vitro Diagnostics (IVDR)

QMD Services GmbH (Notified Body No. NB2962) is a leading Austrian third-party conformity assessment body, authorized by the Austrian National Quality Authority and a proud member of Team-NB, the Medical Device Certification Association. Specializing in MDR and IVDR certifications, QMD offers efficient, compliant pathways for EU market access.

Why QMD?
With the EU’s new, stricter Medical Devices Regulations, many notified bodies have withdrawn, leading both domestic and international companies with fewer options for conformity assessment bodies within the EU. This shortage has resulted in extended waiting times—often several months. This is a disadvantage when the average lifespan of medical devices is between 18 to 24 before newer or better ones replace them. Now, as one of only eleven Notified Bodies in the EU authorized to certify both medical devices and in-vitro diagnostics, QMD Services removes this barrier, providing faster access to market for critical diagnostic products.

Efficient Quotation System
QMD Services recently launched a highly convenient online quotation system that bypasses complex forms and documentation. Clients simply provide basic company and product information to receive a prompt, competitive quote. Access the quotation system here. With market-competitive project quotes and rapid scheduling, QMD Services is an ideal choice for manufacturers seeking MDR/IVDR certification.

If you have any questions, please contact Andy Liang from Shanghai amjs澳金沙门 International (China) Co., Ltd. at andy.liang@ouliyabihua.com.