More Efficiency in the MDR Assessment Process Through Digital Innovation
With the new digital review platform “MAtriX App” from the notified body DQS, you make your MDR product file review efficient, time-saving, and transparent. From uploading your technical documentation to the final review, you manage the entire review process in a centralized digital work environment. Reduce coordination efforts, maintain an overview of the processing status at all times, and improve collaboration with DQS.
What is the MAtriX App?
An optimized end-to-end workflow for your technical documentation
The new review platform uses a user-friendly interface to map out the entire process of reviewing product files in accordance with the MDR in a structured manner: from uploading the customer file through pre-check, clinical pre-check, and evaluation of the technical documentation all the way to non-conformity management and final review.
Increased Efficiency & Time Savings
Significantly reduce processing times for nonconformities and accelerate your compliance processes - systematically, with full documentation, and within a unified work environment.
Greater Transparency & Control
Identify critical nonconformities faster and prioritize open issues effectively - via a user-friendly, intuitive interface with color coding and visual status indicators.
Better collaboration
Keep all project participants on the same page and establish clear responsibilities - with centralized access, transparent project workflows, and controlled submission back to DQS by a designated person.
The Starting Point
Digital Advancements for MDR Assessments.
Discussions with manufacturers made it clear: MDR conformity assessments require clear document workflows, close coordination, and traceable feedback. This is exactly where the new review platform comes in: it centrally consolidates information, evidence, and communication. A direct comparison highlights the difference.
Talk to our team
Schedule an appointment to learn how the new digital review platform makes the evaluation of your technical documentation in accordance with the MDR more efficient and transparent.
The DQS Solution
How customers specifically benefit
Document uploads, nonconformity management, and communication are handled in a single centralized system throughout the entire process, right up to the final review. This reduces administrative overhead, minimizes manual rework, and avoids unnecessary process loops.
- Shorter processing time for nonconformities
- Reduced coordination effort
- Greater focus on high-quality reviews
A modern dashboard displays the status of all projects, open nonconformities, and specific action items in real time. The user-friendly interface allows you to prioritize actions effectively, identify critical issues more quickly, and manage the MDR assessment process securely and transparently.
- All projects at a glance
- Clear prioritization of actions
- Traceably documented process
All project participants work from a shared information base. Clear responsibilities, transparent processes, and centrally consolidated feedback facilitate collaboration and ensure that non-conformity reviews are completed in a structured manner and returned to DQS.
- Centralized access for teams
- Shared Information base
- Transparent project workflows
The Process
The entire testing process in a single system.
The digital platform maps out every step of the conformity assessment in a structured way—cloud-based and accessible at any time, with the current project status visible at a glance on the dashboard.
Customer Upload
You upload your technical documentation directly via the platform.
Preliminary Review
Preliminary review of the submitted documents to ensure they are complete.
TD Assessment
Substantive review of the product dossier by qualified experts.
Final Review
Final evaluation and approval by the technical certifier.
Frequently Asked Questions.
What are the purpose and benefits of the new MAtriX app?
The app fully digitizes our existing process for reviewing technical documentation in accordance with the MDR (EU) 2017/745 and makes it more efficient. It enables the structured handling of all process steps—from uploading the customer file to the final review—in a centralized environment.
Your future benefits:
- Simplified and faster upload
- Overview of all submitted files
- Overview of the processing status of your technical documentation
- Deviation/non-conformity management within the app
Which process steps are mapped in the MAtriX app?
The app covers the following process steps as part of the review of technical documentation:
- Uploading technical documentation
- Preliminary review of technical documentation
- Preliminary clinical review
- Review of the technical documentation
- Deviation/Non-Conformity Management
- Final review
All steps in the app are clearly structured and documented in a traceable manner.
What role does artificial intelligence (AI) play in the MAtriX app?
AI supports the process by:
- detects faulty files as soon as they are uploaded
- summarizing relevant information in a structured way
- enabling quick searches for content from the technical documentation
Important: The AI does not make decisions and does not replace the professional assessment by a qualified reviewer of the technical documentation. It serves exclusively as a support tool.
Who is responsible for decisions in the process?
All technical decisions continue to be made exclusively by the responsible DQS MED staff members.
How are deviations/nonconformities handled?
Deviations/nonconformities are recorded and documented in the app and tracked in direct communication with you. The process for each review round is transparent and enables structured handling until the issue is resolved. You can refer to data that has already been uploaded; alternatively, uploading additional relevant supporting documents is very easy.
Is data security guaranteed?
Yes, the app meets the highest standards for data protection and IT security, including GDPR compliance. All servers on which your data is stored or processed are located in the European Union.
Who can I contact if I have questions about the app?
The app is intuitively designed and self-explanatory. If you have any questions, please feel free to contact your assigned project manager.
Will I continue to use MyDQS?
Yes—the MAtriX app does not replace MyDQS as the central customer portal. Your approved technical documentation report will continue to be available in MyDQS.
Who has access to my technical documentation, and is the data shared with third parties?
Nothing has changed in this regard compared to the previous procedure—all provisions arising from the contract concluded with you regarding secrecy, confidentiality, and data storage remain in effect and will be adhered to.
What file formats can I upload?
The following formats can be uploaded to the app: PDF, DOCX, XLSX, PNG, JPG, TIFF, and ZIP archives.
What is the Clinical Pre-Check?
The Clinical Pre-Check determines whether additional subject-matter-expert clinical reviewers need to be involved in the review of the technical documentation.
What do you need to do to gain access to the MAtriX app?
To gain access to the MAtriX app, the designated contact person at your company must be registered in the MyDQS customer portal. If you have any questions regarding this, please feel free to contact your assigned Customer Service Representative (CSR)—they can provide you with information and, if necessary, add new contacts to the MyDQS customer portal.