The MDIS Solution for MedQAIR
Medical device compliance is becoming increasingly complex, with overlapping requirements across MDR, UK, Swiss, and FDA regulations. For Authorised Representatives (ARs), staying ahead (both pre- and post-market), is a growing challenge.
Traditional tools like file-sharing and manual databases fall short. They delay communication, create regulatory gaps, and make it harder to prove end-to-end compliance.
Here’s how Bridge Global partnered with MedQAIR to solve this: by building a smart, secure document management platform that brings all stakeholders onto one system, simplifies regulatory workflows, and lightens the compliance load.
Requirement Outline
MedQAIR is a leading European Authorised Representative (AR) that offers expert consultancy and end-to-end compliance support across the medical device supply chain. While many tools focus on pre-market approvals, post-market compliance for economic operators remains a gap. To bridge this, MedQAIR partnered with Bridge Global to build a unified, digital platform that streamlines compliance for all stakeholders.
MedQAIR envisioned MDIS as more than a tool for manufacturers. It needed to support the entire economic operator chain, including manufacturers, ARs, importers, and distributors. The platform was designed to simplify post-market compliance and automate complex registrations, especially in national databases like EUDAMED.
Business Challenges
- Traditional file sharing caused delays and communication breakdowns.
- Manual database entries led to inconsistencies and compliance gaps.
- Increasing demand for device registration in multiple national databases (e.g., EUDAMED) added to the complexity.
- Lack of a centralized system made it difficult to maintain consistency, track documentation, and ensure traceable approvals across the supply chain.
Collaboration Highlights
- Started with detailed requirements gathering involving all key stakeholders
- Conducted joint technical meetings to finalize the best-suited architecture and tools
- Followed sprint-wise development, with regular retrospectives, demos, and refinements
- Flow charts and logic diagrams were created to visualize compliance workflows
- MedQAIR brought an existing codebase, which was analyzed, refined, and enhanced
- Tech stack was collectively chosen, prioritizing scalability, compliance, and integration flexibility
Key Features of MDIS
- User-Friendly Interface
The platform boasts an intuitive and user-friendly interface, providing a seamless experience for managing all participants involved in the medical device supply and compliance journey. The well-designed interface ensures that individuals with varying levels of technical expertise can easily navigate and utilize the system for creating, storing, accessing, and managing essential documents.
- Secure & Continuous Access
MDIS ensures continuous and secure access to critical documentation for all authorized stakeholders participating in the compliance and approval processes. Robust security measures are integral to the platform, guaranteeing the protection of sensitive data during both transmission and storage, aligning with stringent security standards prevalent in the healthcare industry.
- Role-Based Access Control
It features role-based access restrictions, ensuring that only authorized personnel can view or modify specific documents, thereby safeguarding confidential information.
- Traceable Approvals
The system meticulously ensures traceable approvals and comprehensive documentation for every stage of the medical device compliance process, maintaining a clear and readily auditable trail of all actions taken.
- Simplified Database Management
MDIS significantly simplifies database management by centralizing and streamlining the handling of data mandated for registration in key national databases such as EUDAMED. It ensures unparalleled consistency and accuracy across multiple database registrations, effectively eliminating the need for redundant data entry and reducing the potential for errors. This centralized approach significantly streamlines the registration process for manufacturers, ARs, importers, and other relevant stakeholders in their respective national databases, saving valuable time and resources.
- Multi-Stakeholder Collaboration
The platform effectively brings together manufacturers, ARs, Persons Responsible for Regulatory Compliance (PRRCs), importers, and distributors, automating and simplifying critical registration processes.
- Effortless Document Verification
MDIS facilitates effortless access and verification of essential documents for all stakeholders, providing clarity on reasons for rejection and other pertinent information.
- Improved Communication & Transparency
The platform promotes improved communication, enhanced collaboration, and greater transparency throughout the entire medical device supply chain, ultimately leading to more robust compliance and significantly improved operational efficiency.
What’s Next: The MDIS Roadmap
To continue evolving MDIS into a comprehensive compliance suite, the following features are in the pipeline:
- Rejection Flow for Distributor/Importer Approvals. A dedicated action page to handle rejections and enable corrective steps
- Improved Data Input for EUDAMED Compliance. Support for multiple dropdowns, dynamic input controls, and API integrations
- 2-Factor Authentication for enhanced security
- Vigilance Module to track incidents and manage reporting
- Integrated Ticketing System for internal issue resolution
- Manual Restart of approval processes for flexibility in complex cases
- Withdraw Device Release from the market, with full audit tracking
- Autoscaling Support to ensure performance during usage peaks
Toward ISO Certification
With MDIS maturing into a central compliance hub, MedQAIR is now aiming for ISO certification. This will:
- Reinforce product credibility with regulatory authorities
- Enhance data security and quality assurance
- Create trust among clients and partners
- Lay the foundation for scaling the platform globally
Expected Business Benefits
As MDIS is gradually rolled out to selected clients, MedQAIR anticipates several key benefits that will enhance their regulatory compliance processes. The platform is expected to reduce the time and effort involved in complex device registration workflows, while also minimizing errors typically caused by manual data entry. Its secure and intuitive interface aims to streamline access to critical documents, enabling the team to work more efficiently and accurately. Overall, MDIS is positioned to improve operational effectiveness, support better data integrity, and create a more scalable, less burdensome path to global medical device markets. Feedback from early users continues to guide refinements ahead of wider adoption.
The technologies we used:
Node.js, Vue.js
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