MedQAIR

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.