MedQAIR is a Dutch consultancy for Quality, Security, and Regulatory Compliance in medical devices and AI-based systems. We work across MDR, IVDR, the EU AI Act, ISO 13485, ISO/IEC 27001, and FDA pathways for EU companies entering the US market.

Our founders, Leon Doorn and Ivo Flipse, built the company on direct experience. Leon has sat across the table from FDA reviewers and Notified Body auditors and knows what an inspectorate finding looks like from the inside. Ivo has built and shipped the software that has to meet these requirements, so our advice reflects how these systems get built and used in practice, not just how the regulation reads on paper.

We support manufacturers, importers, distributors, and Authorised Representatives across the full product lifecycle. Pre-market, we help teams build regulatory strategy, manage cybersecurity and data governance, set up software lifecycle processes, and implement management systems like ISO 13485 and ISO/IEC 27001, along with global market registrations. Post-market, we support economic operators, UDI registrations in EUDAMED and GUDID, audits, post-market follow-up, interim roles like DPO and PRRC, and regulatory due diligence.

MDIS

Regulatory obligations extend beyond the manufacturer. Importers, distributors, and Authorised Representatives carry their own duties under MDR and IVDR, and when a competent authority asks for proof, it needs to be ready. MDIS is our platform for that: it centralizes documentation, UDI identifiers, and verification workflows in one place, so your compliance status is something you can show, not reconstruct.