Ensure EUDAMED compliance by 2026. Use MDIS now for UDI-tracking, documented verifications and EUDAMED registration.
See how it keeps medical device partners (manufacturers, legal representatives, importers, distributors) connected & audit-ready.
Simple, role-based document sharing, streamlined registration & smooth regulatory communication across all stakeholders.
MDIS manages all medical device data across all partners throughout the lifecycle of their devices. Listen to how it simplifies post-market surveillance.
Automate secure document transmission across the entire operator chain.
Ensure fast, accurate delivery of documents to the right stakeholders.
Eliminate errors and delays with automated, streamlined processes.
Stay compliant from product development to market launch.
Maintain a centralized, secure repository for all compliance documents.
Execute documented verification & validation to ensure compliance.
Ensure continuous access to verified documentation for ongoing compliance.
Stay connected to your documentation 24/7, ready for audits or reviews.
Connect with experienced consultants for tailored advice.
Receive expert support on strategic regulatory planning and compliance.
Stay ahead in a fast-moving market with guidance at every step.
Navigate evolving regulatory requirements with ease.
A streamlined platform for traceable, auditable documentation, seamless collaboration, and compliance.
CEO, Co-Founder
A medical device industry professional with 16+ years of expertise in regulatory affairs & quality management, specializing in AI medical devices.
COO, 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.
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.
Principal Consultant
A healthcare informatics expert with 30+ years’ experience in software, quality, and regulatory management, specializing in SaMD and building certified Quality Management Systems.
Consultant
Experienced in EU-MDR and global MedTech regulations, driving strategy and approvals for medical devices, software, and AI across EMEA, North America, and APAC.
Co-Founder
An agile entrepreneur and venture builder, skilled in building IT solutions and high-end consultancy services. Passionate about enabling investors to achieve impact + ROI.
Chief Advisor
An independent strategic advisor with 25+ years of senior leadership experience, focusing on Medical Device compliance globally.
Regulatory Expert
Experienced regulatory affairs consultant in the healthcare industry, specializing in quality systems for medical devices. Authored numerous guidelines and standards for medical technology quality and risk management.
Regulatory Expert
Pragmatic medical device consultant with 35+ years of experience in regulatory compliance, quality management, auditing, and training, ensuring safe and effective medical devices worldwide.
Regulatory Expert
Susan is a global MedTech expert, guiding manufacturers through complex regulations to ensure market access and compliance.
QA & RA Consultant
A seasoned Software as a Medical Device (SaMD) expert, combining regulatory knowledge & AI innovation to deliver compliant medical software solutions.
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.
QA & RA Consultant
A medical device expert with 10 years of experience in SaMD and AI/ML, driving innovation and guiding clients through regulatory approval.
Tech Expert
With a sharp eye for detail and strong problem-solving skills, Sanjay is dedicated to ensuring the optimal performance of our online presence.
Digital Marketing Manager
An expert Digital Marketing Manager & Strategist skilled in digital marketing campaigns and & Customer Experience Management (CX).
Content Lead
An experienced content specialist crafting compelling, high-quality content across various platforms with meticulous attention to detail.
Senior Digital Marketer
A competent digital marketing professional with a flair for innovation and driving successful campaigns.
MDIS is a platform to track and trace Basic UDI, and UDI-DI’s between economic operators, such as the Legal Manufacturer, the Authorised Representative, the Importer and the Distributor. The platform is designed to facilitate secure sharing of technical documentation and accompanying documentation (the IFU and Product Label), ensure compliant documentation reviews by each Economic Operator, and automate registration onto regulatory databases, such as EUDAMED.
The software platform is designed to support the contracted Economic Operator, it can be used by the Legal Manufacturer to manage the downstream Economic Operators, such as the Authorised Representative, the Importer and the Distributor. Similarly, the software platform can be used to manage the upstream Economic Operators, such as an Authorised Representative or Distributor managing multiple Legal Manufacturers, and their provided Technical Documentation and or their Accompanying Documentation, such as the IFU and Product Label per Basic UDI and each consequent UDI-DI.
It is developed to ensure that the technical documentation and accompanying documentation of the Legal Manufacturers is available to each Economic Operator in the medical device distribution chain. In the event of Post-Market incidents, the Economic Operators have continuous access to the latest version of the Documentation, and the system will facilitate Vigilance reporting to regulatory databases, such as EUDAMED through the IMDRF coding systems.
The software platform is designed to support an effortless upload of technical documentation and accompanying documents to facilitate quick and easy sharing across Economic Operators. The technical documentation and accompanying documents are split into separate sections to ensure that each Economic Operator only gains access to those sections relevant to their duties, for example, the Distributor will only gain access to the Labeling materials relevant to their region.
The software platform is designed to automate registration into regulatory databases such as EUDAMED. Once all data for EUDAMED is present, it can be pushed through the EUDAMED API towards EUDAMED, any new UDI-DI added to the system can simply upload the new UDI-DI into EUDAMED, and into future supported databases, such as GUDID and SWISSDAMED.
These are just a few. Visit our FAQ page for more.
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