SCHAUMBURG, Ill., and FRANKFURT, Germany, Sept. 9, 2026 – DQS Inc. this week announced the North American availability of MAtriX, a new digital platform from DQS Medizinprodukte GmbH for reviewing technical documentation under the European Union Medical Device Regulation (MDR). For medical device manufacturers that sell, or plan to sell, products in the EU, the platform gives a centralized view of their MDR assessment process, including project status, feedback, open nonconformities and next steps.
For North American manufacturers, access to the European market requires navigating a regulatory framework separate from U.S. and Canadian requirements. MAtriX brings the review workflow into one digital workspace, replacing process steps previously spread across emails, office files, paper-based checklists and individual storage locations.
“MDR certification is not a one-time transaction. It requires continuity, clear communication and a certification partner that can support products as requirements and portfolios evolve,” said Yuan Li, PhD, Director Medical Business of North America Operations at DQS Inc. “MAtriX gives customers greater visibility into the review process while keeping technical assessments and certification decisions with qualified DQS personnel.”
The platform supports the full technical documentation assessment workflow, from file upload and pre-check through clinical pre-check, technical review, nonconformity management and final review. A dashboard shows active projects, open tasks and current status, while feedback and supplementary documents can be managed within the relevant review process. This shared information base can simplify coordination when multiple team members or product files are involved.
MAtriX also includes AI-assisted features that check uploaded files for potential errors, summarize key information from technical documentation and make content easier to search. The features are designed to reduce manual effort and support more efficient processing; technical assessments and certification decisions remain with responsible DQS personnel. The platform is fully GDPR compliant and was developed to meet DQS requirements for data protection and IT security.
The launch comes ahead of Commission Implementing Regulation (EU) 2026/977, which applies beginning Feb. 25, 2027. The regulation establishes more uniform requirements for key Notified Body processes, including quotations, assessment timelines, deadline interruptions and monitoring of duration and costs. Since it does not require a specific software platform, it increases expectations for traceable, coordinated and transparent review processes.
“The requirements placed on manufacturers and Notified Bodies are increasing. It is all the more important that available expertise is not tied up in manual search processes and unnecessary coordination loops,” said Marco Deuschler, Head of Medical Notified Body and Certification Body at DQS Medizinprodukte GmbH. “A digital review process can free up time and help ensure that technical resources are deployed where they are truly needed: for a reliable assessment.”
The MAtriX platform is available at no additional charge to DQS customers. More information can be found at https://www.dqsglobal.com/en/contact/matrix-app.
About DQS
DQS Inc. is the U.S. office of the DQS Group. MDR conformity assessments are conducted by DQS Medizinprodukte GmbH, a DQS Group company and Notified Body designated under Regulation (EU) 2017/745.
DQS Group is a global specialist in the assessment and certification of management systems. Founded in 1985, DQS operates in more than 80 countries, with 3,000 highly qualified auditors conducting more than 130,000 audit days annually across 200+ internationally recognized standards. DQS Inc. helps organizations manage risk, demonstrate compliance and strengthen performance through auditing and certification services spanning quality, information security, sustainability, artificial intelligence, healthcare and manufacturing. For more information, visit https://www.dqsglobal.com/en/.
