Company intelligence
MedQAIR
Your Global Compliance Partner for Medical Devices, IVDs & AI | Regulatory and Quality Experts | Creators of MDIS
About 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. ππΌπΏπ² π¦π²πΏππΆπ°π²π 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.
Verified activity
Signals from MedQAIR
9 published signals
Presence & Recognition
MedQAIR attended the European SaMD Meetup on 21 September 2026 featuring Dominik Kowalski, Senior Project Manager, Regulatory Compliance at Brainlab / SNAIG, to discuss IEC TC 62 standards and SNAIG roadmap updates.
Reported by MedQAIR
Presence & Recognition
MedQAIR notes that at the next European SaMD Meetup, Dominik Kowalski from Brainlab/SNAIG will provide an overview of IEC TC 62 standards and share an update on the SNAIG roadmap.
Reported by Ivo Flipse
Presence & Recognition
MedQAIR participated in the next European SaMD Meetup to discuss the Status of the AI Act and Standards.
Reported by Ivo Flipse
Legal & Regulatory
MedQAIR notes that Switzerland is preparing to extend its integrity and anti-inducement rules to the medical device sector.
Reported by MedQAIR
Customers & Market
MedQAIR supported Synaptiq.io with their Technical File and Clinical Evaluation, notified body findings, and technical review.
Reported by MedQAIR
Presence & Recognition
MedQAIR is hosting the next European SaMD Meetup on 21 September 2026 for the Status of the AI Act and Standards discussion.
Reported by MedQAIR
Presence & Recognition
MedQAIR CEO Leon Doorn will host a session at the TOPRA 2026 Regulatory Affairs Symposium in Utrecht, Netherlands, exploring legislative changes for AIaMD and SaMD.
Reported by MedQAIR
Presence & Recognition
MedQAIR highlights that Monique Greijmans will speak at the TOPRA Symposium 2026 in Utrecht on IVD regulatory changes and expectations.
Reported by MedQAIR
Presence & Recognition
MedQAIR announced that Leon Doorn will be lecturing at the European Workshop on AI in Neuroimaging on βBridging Minds and Machines: AI Implementation and Human-AI Interaction in Neuroradiologyβ on 16 October 2026.
Reported by MedQAIR