Regulatory Fast-Track Assessment Packages
Get clarity within 48 hours: built for startups, Healthtech, Medtech companies, and teams needing quick, reliable direction
LIGHT REGULATORY ASSESSMENT
A concise, cost-effective assessment focused on giving you fast clarity
1,699
Delivery Time: 48 hours
- Device / Software qualification (Medical Device / SaMD / IVD)
- Initial risk class determination (EU MDR / IVDR / FDA / UAE MOHAP)
- Summary regulatory pathway for your first target market
- High-level documentation list
- Identification of major compliance gaps
- Recommended next steps and early feasibility guidance
FULL REGULATORY PATHWAY REPORT
A comprehensive, submission-ready roadmap covering all major regulatory frameworks and market entry considerations
2,699
Delivery Time: 5 working days
Includes authority confirmation letter (where applicable)
- Full qualification analysis (SaMD / AI / IVD / Device)
- Detailed MDR / IVDR classification + rule justification
- FDA device classification + predicate mapping (if applicable)
- Complete UAE MOHAP / DHA / DOH pathway analysis
- Required documentation list (Design, QMS, Clinical, Risk, PMS)
- Clinical evaluation / performance evaluation expectations
- Cybersecurity, PDPL, ICT Health Data Law considerations
- AI Act classification (for AI/ML products)
- Regulatory timeline + submission strategy
- Communication with relevant health authorities
- MOHAP / DOH / DHA confirmation email/letter where applicable
- Final Report (PDF) ready for investors or internal planning
Which Package Should You Choose?
Stage / Need
Recommended Package
Idea or concept-phase
1,699 AED Light Assessment
Need quick classification & feasibility
1,699 AED Light Assessment
Preparing investor materials
2,699 AED Full Report
Need official clarity for MOHAP/DHA/DOH or NB/FDA
2,699 AED Full Report
Have multiple markets in scope
2,699 AED Full Report
AI/ML or complex SaMD
2,699 AED Full Report