MedQAIR provides end-to-end regulatory and quality compliance support for medical devices, IVDs, and AI-enabled health technologies across global markets, including the EU (EU MDR, IVDR), US (FDA), and Canada (Health Canada).

We support manufacturers across both pre-market and post-market phases, ensuring efficient market access and continuous compliance throughout the product lifecycle.

𝗖𝗼𝗿𝗲 𝗦𝗲𝗿𝘃𝗶𝗰𝗲𝘀

Authorised Representative (AR) | PRRC | Regulatory Strategy & Technical Documentation | EUDAMED & UDI Management | Vigilance & Post-Market Surveillance | AI & Software Compliance

To simplify compliance between Economic Operators / medical device partners, MedQAIR developed MDIS (Medical Device Information System) - a secure, ISO 27001-certified platform that:

- Tracks Basic UDI & UDI-DIs
- Automates EUDAMED registrations and updates
- Enables secure sharing of technical documentation
- Supports vigilance reporting and audit-ready traceability

Together, our expert consulting and MDIS platform help manufacturers maintain compliance, ensure transparency, and respond rapidly to post-market obligations.

MedQAIR

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