Fast-Track Packages

Regulatory Fast-Track Assessment Packages

Get clarity within 48 hours — built for startups, HealthTech and MedTech companies, and teams needing quick, reliable direction.

Fast clarity

Light Regulatory Assessment

A concise, cost-effective assessment focused on giving you fast clarity.

AED1,699
Delivery time: 48 hours
Get started
  • 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
Submission-ready roadmap

Full Regulatory Pathway Report

A comprehensive, submission-ready roadmap covering all major regulatory frameworks and market entry considerations.

AED2,699
Delivery time: 5 working days
Includes authority confirmation letter (where applicable)
Get started
  • 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
Choosing a Package

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
ComplianceMedQRA AssistantOnline — usually replies instantly

Hi — I'm the ComplianceMedQRA assistant.

Ask me about our services, the markets we cover, how our engagements are structured, or how to reach the team.

Pick a topic below, or just type your question.

Suggested
Answers common questions only. For anything specific, email info@compliancemedqra.net.