Services Tailored to SaMD, AI, and Modern MedTech
Pragmatic, lean, and regulator-ready quality and regulatory support
Regulatory Strategy & Global Market Access
We turn regulatory complexity into a clear, executable plan, aligned with your product, risk class, and markets
Regulatory Pathway Assessments
MDR / IVDR classification, SaMD qualification, IVD risk classes, UAE MOHAP/DHA/DOH pathway
EU MDR & IVDR Support
Technical documentation, GSPR mapping, risk management integration
AI & SaMD Regulations
AI/ML change management, EU AI Act classification and risk controls (for high-risk AI systems), SaMD standards (IEC 62304, IEC 82304-1)
UAE & GCC Market Entry
MOHAP registration, DHA/DOH pathways, local representation, documentation structure, and authority Q&A support
FDA & North America
510(k), De Novo, Q-Subs, IDE, and US reimbursement considerations. Review of indications, predicate mapping, and clinical evidence strategy
Quality Management Systems for Modern MedTech
Whether you’re just getting started or scaling to multiple markets, we design and implement QMS frameworks that actually work for your business
ISO 13485 QMS Design & Implementation
Gap analysis, process design, SOPs, templates, and practical roll-out
Risk Management (ISO 14971)
Risk files for SaMD, AI, IVD, and devices, integrated with design control and clinical evaluation
Audit Readiness & Remediation
Internal audits, supplier audits, mock inspections, CAPA planning, and remediation tracking
Post-Market Surveillance & Vigilance
PMS plans, PMCF/PMCF plans and reports, complaint handling, incident reporting, trend analysis
Fractional QA/RA Leadership
Interim or part-time QA/RA lead to bridge gaps until you build your internal team
eQMS Implementation with QraOne
We help you move from scattered documents and spreadsheets to a structured, audit-ready eQMS powered by QraOne
Mapping your existing processes and documentation into QraOne
Configuring modules (Document Control, Design Control, Quality Events, Supplier Management, Training)
Migrating legacy documents and records
Defining workflows, permissions, and traceability links
Training your team and providing ongoing support
Data Protection, PDPL, and ICT Health Data Law
Digital health and AI products live and die by how they handle data. We help you align your product and operations with UAE, EU and global expectations
UAE PDPL and ICT Health Data Law assessments
Alignment with GDPR principles where relevant
Records of Processing Activities (ROPA) and legal basis mapping
Cross-border data transfer and cloud architecture considerations
Integration of privacy and security into your QMS and technical documentation
Alignment with SOC 2 / ISO 27001 frameworks (where applicable)
Training and Regulatory Enablement
FDA, MDR/IVDR, UKCA & GCC regulatory fundamentals.
SaMD, AI & digital health regulatory essentials.
QMS, ISO 13485 & QraOne platform training.
Founder, clinical & investor readiness workshops.
