Compliance & QRA that accelerate MedTech, SaMD, and AI products to market without compromising regulatory confidence
 -UAE - Nursing Manthra.webp)
End-to-End Compliance for Digital Health & Medical Devices
Regulatory Strategy & Submissions
MDR, IVDR, FDA, MOHAP/DHA/DOH, Health Canada, GCC, and more tailored roadmaps and submission support for SaMD, AI/ML, IVD, and devices
Quality Management Systems (QMS)
ISO 13485-aligned QMS design, implementation, audits, remediation, and fractional QA/RA leadership
QraOne eQMS for Startups & Scaleups
Cloud eQMS designed for MedTech & SaMD teams. AI-assisted document control, design control, CAPA, and more - all in one place
Don't just take our words
Compliance MedQRA has been an invaluable partner in our compliance journey. Not only is their mastery of PDPL impressive, but their commitment to meeting deadlines and providing timely support is exceptional. Their team goes beyond just 'checking boxes' - they offer strategic insights that have genuinely strengthened our operations. It has been a pleasure collaborating with such a professional and dedicated group.Klaudia Cho
CEO, MediLink360
Compliance MedQRA has been a reliable partner in supporting our regulatory and quality needs. Their structured approach, clear guidance, and deep understanding of regulatory requirements, particularly in ISO 13485 QMS implementation, have been extremely valuable to our team. The QraOne eQMS tool has also been very useful in streamlining our quality processes and improving overall compliance readiness.Laura Towart
Founder & Chief Executive Officer, Vivan Therapeutics
Compliance MedQRA has been supporting us on our EU MDR compliance journey for our Class III implantable medical device. Their clear, structured guidance and strong understanding of EU MDR requirements have helped us navigate complex regulatory expectations with confidence. In parallel, their QraOne QMS platform provides a strong framework for structure and management of our quality processes. We value their professionalism continued support, and consider Compliance MedQRA a trusted partner in our EU MDR journey.Jordan Pollack
Co-Founder & CEO, Sub-Q Bionics Inc
Compliance MedQRA has provided clear and reliable regulatory guidance throughout our medical software compliance journey, including QMS certification under ISO13485, EU MDR, U.S. FDA, UK MHRA, MDSAP, GDPR, HIPAA, and DICOM compliance. Their strong understanding of medical device regulations, combined with a practical and well-structured approach, helped us navigate complex compliance obligations efficiently. We value their professionalism, responsiveness, and regulatory expertise, and would recommend Compliance MedQRA as a trusted regulatory partner.Mads Fiig
CEO, Brainreader A/S
Built for Innovators in Healthtech & Life Sciences
We support teams across the full health-tech ecosystem
SaMD & AI-enabled Digital Health
Clinical decision support, imaging AI, remote monitoring, DTx and more
Medical Devices & Wearables
Hardware and connected devices, from fall detection and early warning systems to sensors and home-use devices
IVD & Genomics / Precision Medicine
IVD software, oncology decision support, and complex data-driven diagnostics
Pharma & Life Sciences
Companion software, combination products, and data-intensive solutions
Why to Choose
Compliance MedQRA
Deep SaMD & AI Expertise
We live in software, AI/ML, and real-world MedTech - not generic consulting
Hands-On, Not “Slide-Deck Only”
We write your procedures, build your technical documentation, and guide your teams through audits and submissions
Hybrid UAE EU Presence
Strong understanding of EU MDR/IVDR, FDA, and UAE/GCC (MOHAP, DHA, DOH, PDPL, ICT Health Data Law)
Integrated with QraOne eQMS
We don't just advise; we give you the tool to execute and sustain compliance
QraOne - Our eQMS Built by MedTech QRA Experts
QraOne is our cloud-based eQMS designed for MedTech, SaMD, and digital health companies that want serious compliance without enterprise complexity
40% efficiency gain compared to typical spreadsheet-based QMS and legacy tools
Purpose-built modules for design control, AI-enabled document search, and quality events
Startup-friendly pricing and implementation support by the same consultants who design your QMS
From Early-Stage Startups to Global Players
We support Healthtech, Medtech companies, regulatory leaders, and product teams across Europe, the Middle East, North America, and India - from early-stage ventures validating their first SaMD to established companies expanding globally
Ready to Make Compliance a Competitive Advantage?
Whether you’re defining your first regulatory strategy, preparing for FDA, CE (MDR/IVDR), or GCC market entry or remediating an existing compliance program we help you move faster, with less stress, and fewer surprises from regulators