QMD Services

medical devices

About

QMD Services is an Austrian-based notified body that specializes in the conformity assessment and certification of medical devices and in-vitro diagnostics (IVD) for the European market. Established in December 2018 by Quality Austria, the company operates under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), ensuring that products meet stringent safety and performance standards. The company provides a comprehensive range of services, including certification of medical devices and IVDs, system certification for quality management systems, and professional assessment processes. QMD Services focuses on patient safety, independence, and regulatory compliance, offering support to manufacturers and sales organizations in obtaining necessary approvals for the European market. With a team of international experts, QMD Services emphasizes detailed evaluations and risk-benefit analysis to facilitate market access for medical technologies. Headquartered in Vienna and Linz, Austria, the company serves both local and international clients.

Technologies

Outlook Microsoft Office 365 Apache WordPress.org Mobile Friendly

Keywords

ivdr mdr & ivdr iso13485 mdr notified body quality management system conformity assessment regulatory standards device performance assessment b2b medical device regulation surveillance audits technical documentation review medical devices certification process medical technology device lifecycle management device safety assessment ce marking regulatory audit services european market access all other ambulatory health care services clinical data evaluation clinical evidence collection device safety innovation product risk classification safety standards clinical evaluation clinical evidence

Location

10 Zelinkagasse, Vienna, Vienna, Austria, 1010

Related Companies

Companies in the same industry