Share securely
Share technical documentation and labelling with importers and distributors.
Digital AR by MedQAIR
Your Fully Digital Authorised Representative
Our Digital AR services enable streamlined, fast, continuous, and secure sharing and review of technical documentation, easy UDI management, and built-in EUDAMED connectivity.
Digital-first representation
How We Are Different
Manufacturers securely upload technical documentation and labelling, initiate verification flows, and coordinate EUDAMED registrations through the same system.
Fast Setup and Approval
Once the Authorised Representative agreement is signed, upload your documentation. Our experts review it and communicate approval through the platform, allowing supported devices to go live quickly.
Talk To Our Experts ↗Quick and Efficient Change Management
Our workflow is designed for speed and traceability, especially for software and AI-based devices where frequent updates require agile oversight.
- Class I: focused review of the Declaration of Conformity and key changes.
- Class IIa / IIb: Article 11 documentation-presence review within 72 hours.
- Class III / IIb implantable: review focused on Article 11 and safety- or performance-relevant changes.
Connected compliance
There Are More Advantages
MDIS extends your Authorised Representative service across the economic-operator chain.
Always available
Provide 24/7 access to authorised stakeholders.
Role-specific access
Ensure each party only views documentation relevant to its role and region.
Transparent Compliance
Every verification and approval step is traceable and documented. Contracts, verification steps, and mandatory documentation remain available as clear, auditable records.
Full European Coverage and Beyond
MedQAIR can act as your digital Authorised Representative across the European Union and collaborates with partners in the United Kingdom, Switzerland, and further regions.
ISO/IEC 27001 Compliant
Our information-security management system supports the confidentiality, integrity, and availability of your documentation and platform workflows.
Digital-first oversight
Experience a Digital-First Approach to Authorised Representation
See how MedQAIR simplifies medical device documentation management, compliance workflow automation, and transparent oversight for manufacturers and PRRCs.
Meet The Team
Our Experts
Leon Doorn
CEO, Co-Founder
A medical device industry professional with 16+ years of expertise in regulatory affairs & quality management, specializing in AI medical devices.
Monique Greijmans
Regulatory & Quality Expert
Experienced in complex MedTech product development, driving compliance from early strategy to market launch across medical devices, IVDs, MDSW, and AI-based solutions.
Ivo Flipse
Co-Founder
An SaMD expert with 15+ years of experience specializing in MDR, and FDA compliance with a focus on cybersecurity and software lifecycle management.
Trudy Kunnen
Principal Consultant
A healthcare informatics expert with 30+ years’ experience in software, quality, and regulatory affairs across medical devices, IVDs, AI, and clinical IT.
Eva Kurilova-Sahin
Consultant
Clinical scientist with 10 years’ experience across clinical research and medical AI, with growing expertise in regulatory affairs for healthcare technology.
Maurice Veerkamp
Consultant
A seasoned Software as a Medical Device (SaMD) expert, combining regulatory know-how with hands-on software development experience.
Lauren Perez
Jr. Quality & Regulatory Consultant
Biomedical Sciences graduate supporting quality and regulatory activities with experience in data integrity, documentation, and research processes.
Mike Graney
Business Development Executive
With 20+ years in economic development, including 10 at CRDA, Mike now leads Graney LLC, advising clients like MedQAIR. He specializes in FDI, life sciences, and transatlantic investment.
Hugo Messer
Co-Founder
An agile entrepreneur and venture builder, skilled in building IT solutions and remote teams across the globe.
Sarah Smith
QA & RA Consultant
A medical device expert with 10 years of experience in SaMD and AI/ML, driving innovation and compliance in healthcare technology.
Sanjay M
Tech Expert
With a sharp eye for detail and strong problem-solving skills, Sanjay is dedicated to building robust, scalable technology solutions.
Yedu Panicker
Digital Marketing Manager
An expert Digital Marketing Manager & Strategist skilled in digital marketing campaigns, lead generation, and brand growth.
Preethi Philip
Content Lead
An experienced content specialist crafting compelling, high-quality content across formats to connect with diverse audiences.
Sandeep P
Digital Marketing Manager
A competent digital marketing professional with a flair for innovation and driving measurable growth through data-led campaigns.
Frequently Asked Questions
Find answers to common questions about our services, compliance processes, and how we can assist your business.
What is a Digital Authorised Representative for Medical Devices?
A Digital Authorised Representative (Digital AR) combines regulatory expertise with a secure, cloud-based compliance platform. Unlike traditional ARs that rely on emails and manual document exchange, MedQAIR provides continuous access, verification, and approval of Technical Documentation through a single digital system. This ensures full traceability, faster reviews, and simplified communication between authorised representatives and the connected manufacturers, PRRCs, importers, and distributors.
How does MedQAIR’s platform support PRRC compliance and oversight?
MedQAIR uses a software platform (‘MDIS’), which includes a dedicated PRRC role to demonstrate compliance. Each PRRC, whether internal or external, can receive assigned tasks, review documentation, and document approvals in a traceable manner. Every action is timestamped, creating a clear audit trail that aligns with MDR and IVDR requirements.
How does MedQAIR simplify medical device documentation management?
The medical device compliance platform centralizes all technical documentation, CE certificates, and (localised) labelling materials. Manufacturers and Economic Operators or medical device partners can securely upload, review, and share documentation, ensuring that only authorized users can access relevant sections as granularly shared by the manufacturer. This structure replaces fragmented file sharing with a unified, compliant medical device documentation management system.
Can the MedQAIR platform help automate compliance workflows?
Yes. MedQAIR’s compliance workflow automation allows manufacturers to initiate verification flows for all Basic UDI-DIs and subsequent UDI-DIs, manage approvals, and push registration data directly into EUDAMED. This reduces repetitive manual checks, ensures consistency, and speeds up the device approval process while maintaining regulatory accuracy across regions.
In which regions can MedQAIR act as an Authorised Representative?
MedQAIR serves as a digital Authorised Representative for medical devices across the European Union, the United Kingdom, and Switzerland (and other countries to come).
Our digital authorised representative platform is designed to adapt to country-specific regulatory frameworks and will soon extend coverage to additional global regions in cooperation with local compliance partners.