QMD Services further expands MDSAP offering to support global market access

QMD Services GmbH (Notified Body 2962) continues to strengthen its international service portfolio by further expanding its established partnership with UL Solutions for the provision of Medical Device Single Audit Program (#MDSAP) certification.

MDSAP: The Next Step in International Collaboration

Building on a successful collaboration initiated in 2025, QMD now brings this partnership to the next level, enabling broader access to MDSAP services for its clients and a more integrated approach to global regulatory compliance.

As the only Notified Body in Austria designated under both Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), and one of only 19 Notified Bodies in the European Union with dual designation, QMD is uniquely positioned to support manufacturers in navigating both European and international requirements.

Greater Efficiency in Global Market Access

Through the enhanced MDSAP offering, clients can benefit from increased alignment of audit activities and, where feasible, coordinated certification cycles. This approach supports more efficient use of resources while maintaining the high level of regulatory rigor expected from a Notified Body.

An Integrated Pathway to Global Market Access

In combination with ISO 13485 certification provided via the long-standing partnership with Quality Austria, QMD offers a comprehensive and integrated certification pathway covering European CE marking and key global market requirements.

With headquarters in Vienna, an operational office in Linz, and a network of experts and qualified partners across multiple regions operating under QMD supervision, we ensure consistent, high-quality service delivery worldwide.

This evolution of our service portfolio enables manufacturers of medical devices and in vitro diagnostics to pursue a structured and efficient pathway to both EU market access and international expansion.

About QMD Services GmbH

QMD Services GmbH (Quality Medical Devices) was founded in December 2018 as a subsidiary of Quality Austria with the aim of becoming a European Notified Body for medical devices and in vitro diagnostic medical devices in Austria under EU Regulations (EU) 2017/745 and 2017/746. The company is headquartered in Vienna and has an additional location in Linz. QMD Services has access to an international team with many years of experience in the industrial and healthcare sectors.

Since December 23, 2022, QMD Services has been authorized to carry out conformity assessment activities for in vitro diagnostic medical devices and also benefits from Quality Austria’s many years of experience in medical device certification (ISO 13485). Since 2024, it has been Austria’s national Notified Body for medical devices.