DQS launches MAtriX MDR platform for North America

DQS has launched its MAtriX digital MDR assessment platform in North America for medical device manufacturers seeking access to the European Union market, as new EU rules on notified body processes approach.

The platform is designed to give manufacturers a central view of their assessment process under the European Union Medical Device Regulation, or MDR. It shows project status, feedback, open nonconformities and next steps in a single digital workspace.

Medical device makers in the US and Canada that want to sell products in the EU must navigate a regulatory system that differs from their domestic regimes. MAtriX is intended to move a workflow often spread across emails, office files, paper checklists and separate storage locations into one system.

According to DQS, the platform covers the full technical documentation assessment process, from file upload and pre-checks through clinical pre-check, technical review, management of nonconformities and final review. A dashboard tracks active projects, open tasks and current status, while users can manage feedback and supplementary documents within the relevant review process.

DQS said this shared information base may help when several team members are involved or when manufacturers are handling multiple product files at once. The platform is available to DQS customers at no extra charge.

Process changes

The rollout comes ahead of Commission Implementing Regulation (EU) 2026/977, which introduces more uniform requirements for key notified body processes. Those requirements cover quotations, assessment timelines, deadline interruptions, and the monitoring of duration and costs.

Although the regulation does not require any specific software platform, it raises expectations for review processes that are traceable, coordinated and transparent. That creates an incentive for notified bodies and manufacturers to use systems that document progress and communication more consistently.

DQS said MAtriX was developed by DQS Medizinprodukte, the group company responsible for MDR conformity assessments as a designated notified body under the EU framework. In North America, the product is being offered through DQS, the group's US office.

The platform also includes AI-assisted functions. DQS said these tools can check uploaded files for potential errors, summarise key information from technical documentation and improve searchability within submitted content.

Technical assessments and certification decisions remain with qualified personnel rather than the software, according to DQS. The company also said the system is fully compliant with the General Data Protection Regulation and was developed to meet internal requirements for data protection and IT security.

Yuan Li, PhD, director of medical business for North America operations at DQS, outlined the company's view of the market need. "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," Li said.

Li added: "MAtriX gives customers greater visibility into the review process while keeping technical assessments and certification decisions with qualified DQS personnel."

Market context

The EU Medical Device Regulation has increased the compliance burden on manufacturers and notified bodies since replacing the previous directives. Companies seeking certification must submit technical documentation for review, respond to findings and track changes as products and portfolios develop.

That process can be difficult to manage when documents, reviewer comments and action points are spread across different channels. Digital tools that centralise communication and document handling have become more relevant as notified bodies face pressure to manage workloads and maintain clear audit trails.

DQS describes itself as a global specialist in the assessment and certification of management systems. The group says it operates in more than 80 countries and has 3,000 auditors carrying out more than 130,000 audit days each year across more than 200 standards.

Marco Deuschler, head of medical notified body and certification body at DQS Medizinprodukte, linked the launch to rising regulatory and operational demands. "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," Deuschler said.

He added: "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."