Expanded service offering with IVDR certification
UL Solutions has formed a strategic relationship with the Austrian notified body, Quality Medical Devices (QMD ) Services GmbH, to offer certification services based on EU Regulation 2017/746, the In Vitro Diagnostic Medical Devices Regulation (IVDR). This collaboration strengthens our commitment to delivering certification and auditing services by expanding our portfolio to include a full suite of quality management (QM) auditing and certification offerings for the medical device and in vitro diagnostic (IVD) industries.
Comprehensive suite of services to help you demonstrate compliance
Our expanded offerings can help your products demonstrate compliance with stringent IVDR requirements.
The collaboration enables us to further support you with:
- Expert guidance – Seamless navigation of IVDR requirements with support from our experienced team and QMD.
- Comprehensive compliance solutions – From auditing to certification, we cover every stage of the IVDR process together.
- Streamlined certification pathways – Accelerate your market access with expert review and assessment, supporting an efficient and compliant route to market.
Why work with UL Solutions?
Proven regulatory expertise
Access to global teams that are deeply experienced in IVDR requirements and other international quality standards.
Efficient audit-ready processes
Our streamlined workflows and tools help you prepare with confidence to maintain readiness throughout the product life cycle.
Scalable services that grow with you
Whether you're entering the EU market for the first time or expanding your portfolio, we offer a comprehensive suite of global offerings that match your needs.
Our QM auditing and comprehensive suite of certification offerings include:
- IVDR certification services – CE certification based on EU Regulation 2017/746 for IVDs.
- Medical Device Regulation (MDR) certification services – CE certification in accordance with EU Regulation 2017/745 for medical devices.
- ISO 13485 – Quality management for medical devices certification: Quality management system (QMS) certification tailored for medical devices.
- Medical Device Single Audit Program (MDSAP) certification – QMS audit certification a cross multiple countries through the MDSAP.
- UKCA Certification for IVDs and medical devices – Certification for compliance with UK Medical Devices Regulations 2002 for in vitro diagnostic and medical devices.
- INMETRO certification for Brazil – Certification supporting compliance with Brazilian safety and quality standards for medical devices.
Ready to take the next step towards IVDR compliance? Our team is here to guide you through the process with confidence and expertise.
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Contact us today
Contact us today to learn more about our IVDR services and how our new collaboration can support your business in meeting regulatory requirements and streamlining market access.
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