Medical device + AI compliance across pre-market, post-market, and MDIS-enabled operations.
AI Gap Analysis finds evidence. MedQAIR consultants expand that into regulator-ready execution across SaMD/AI strategy, quality systems, economic-operator obligations, and post-market workflows.
What they help with.
MedQAIR provides expert consulting across these key areas.
Regulatory
- Regulatory strategy for medical devices, SaMD, and AI-enabled products across EU and US pathways
- Submission support for major routes including MDR/IVDR and FDA-oriented dossiers
- AI-focused compliance planning, including support for evolving AI regulatory obligations
- Country registration support for global market access execution
- Economic-operator support including EU Authorised Representative and UKRP contexts
Quality
- QMS implementation, remediation, and upgrade programs
- ISO 13485-focused quality system design and operationalization
- ISO/IEC 27001-aligned information-security process integration
- Templates, workshops, and practical enablement for internal teams
- Evidence traceability architecture for regulator and auditor review
Clinical
- Clinical writing support for protocols, reports, and submission documentation
- Biocompatibility strategy with planning and test-documentation coordination
- Electrical safety and pre-clinical evidence packaging support
- Cross-functional evidence assembly for high-stakes regulatory milestones
Audit
- Internal and supplier audit support for medical device organizations
- Audit readiness reviews against ISO 13485 and related obligations
- Post-market vigilance process setup and periodic reporting support
- Interim RA/QA capacity to stabilize quality and compliance operations
- MDIS-assisted document control and partner-chain traceability for inspections
How teams use this together.
Typical workflows that combine Outwrit with MedQAIR's expertise.
Run AI Gap Analysis for first-pass evidence mapping, then use MedQAIR reviewers to stress-test weak claims before sign-off.
Build a regulator-facing package for SaMD or AI-enabled devices with clearer traceability from requirement to evidence.
Prepare distributor, importer, and legal representative teams for documented obligations and audit scrutiny.
Stand up post-market workflows for incident handling, periodic reporting, and continuous documentation access.
Use MDIS to coordinate manufacturer-operator document exchange, UDI-linked records, and EUDAMED-facing workflows.
Convert partial findings into a prioritized remediation backlog with RA/QA ownership and implementation sequencing.
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.
Articles and publications.
MDIS & Platform
Recent Resources
Regulatory Updates in Medical Devices, Cybersecurity & AI, February 2026
Regulatory-news summary covering medical device, cybersecurity, and AI developments.
MDR Transition Requirements for Legacy Devices in 2025 and 2026
Practical implications for maintaining legacy devices under MDR transition rules.
Medical Device Compliance: How Manufacturers Stay Audit-Ready
Operator-focused implementation guidance for manufacturer responsibilities.
Medical Device Compliance: How Importers Stay Audit-Ready
Operational checklist and obligations for importers in regulated markets.
Medical Device Compliance: How Distributors Stay Audit-Ready
Distributor role clarity and documentation expectations for compliance teams.
MedQAIR Resources Hub
Browse case studies, regulatory news, blog articles, and events from MedQAIR.
About MedQAIR.
MedQAIR is a medical device and AI compliance consultancy providing pre-market and post-market support across EU and US pathways, with dedicated services for software, AI, quality systems, and market operations.
Their service lines cover software as a medical device, AI-focused regulatory strategy, electrical safety, biocompatibility, clinical writing, and management-system implementation.
For post-market needs, MedQAIR offers interim RA/QA support, audits, economic operator services (including EU Authorised Representative and UK Responsible Person roles), vigilance support, and country registration support.
MedQAIR also offers MDIS (Medical Device Information System), a platform they position for UDI tracking, documented verification, EUDAMED registration workflows, and auditable cross-partner documentation.
Their public resources include regulatory updates, implementation guidance, and practical compliance content for manufacturers, importers, and distributors.
MedQAIR Expert Review (optional add-on): €250/hr. Includes a 1-hour review. Extra time only proceeds with your approval.
Ready to work with MedQAIR?
Combine evidence discovery with expert consulting for audit-ready compliance.
Partner services are delivered by MedQAIR. AI Gap Analysis provides software tooling for evidence discovery. Always apply professional judgment.