Regulatory
- EU and US regulatory strategy for medical device and AI-enabled products
- Technical documentation support for submissions
- EU Authorised Representative and PRRC services
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MedQAIR
Medical device + AI compliance. Optional expert review for audit-ready confidence.
Website: medqair.com
What they help with
Quality
- QMS implementation and upgrades
- ISO 13485-focused quality system support
- Evidence traceability and audit readiness reviews
Clinical
- SaMD risk and evidence review support
- Cross-functional alignment for high-stakes audit scenarios
Typical use cases with AI Gap Analysis
- Run a first-pass evidence map, then have experts challenge weak links before finalizing conclusions.
- Prepare AI medical device documentation with traceable evidence tied to framework clauses.
- Pressure-test findings before audits where evidence quality matters more than speed.
- Convert partial findings into a prioritized remediation plan with clear owner actions.
Meet the experts
Ivo Flipse
COO, Co-Founder. SaMD expert with MDR/FDA focus, cybersecurity, and software lifecycle depth.
Leon Doorn
CEO, Co-Founder. 16+ years in regulatory affairs and quality management for AI medical devices.
Maurice Veerkamp
Consultant. SaMD specialist combining regulatory knowledge with practical AI implementation.
Hugo Messer
Co-Founder.
About
MedQAIR is a medical device and AI compliance consulting company supporting regulatory, quality, and security compliance across EU and US pathways.
Their team supports AI/ML-enabled medical devices, SaMD cybersecurity and software lifecycle compliance, and documentation for regulator-facing submissions.
MedQAIR also operates as an EU Authorised Representative, provides PRRC services, and states it is ISO/IEC 27001:2022 certified.
Expertise highlights
- AI/ML-enabled medical device regulatory consultation and strategy.
- EU AI Act gap assessments and implementation support.
- QMS implementation and upgrades, including ISO 13485 programs.
- Technical documentation support for EU and FDA pathways, including 510(k) and PMA context.
- Cybersecurity and software lifecycle compliance for SaMD.
- Regulatory and quality execution across US and EU pathways.
MedQAIR Expert Review (optional add-on): €250/hr. Includes a 1-hour review. Extra time only proceeds with your approval.
Disclaimer
Partner services are delivered by MedQAIR. AI Gap Analysis provides software tooling for evidence discovery. Always apply professional judgment.