Turning Regulatory Complexity into Market Opportunity

We help innovators define the right regulatory pathway, build compliant quality systems and achieve efficient market access across global jurisdictions.

Clear scope and deliverablesHands-on expert supportGlobal market experience
YOUR
PRODUCT
US FDA510(k) · De Novo · PMA
US FDAFDA classification & pathway strategy, Q-Submissions, 510(k), De Novo, PMA, QMSR, clinical evidence, AI/PCCP and cybersecurity support.
EU & UKMDR · IVDR · UKCA
EU & UK Market AccessCE Marking, EU MDR/IVDR and UKCA strategy, product classification, conformity assessment planning and technical documentation preparation.
UAE, Saudi & GCCEDE · MOHAP · SFDA
UAE, Saudi & GCCProduct classification, local regulatory pathway, authority submissions, registration support and market-entry planning across the UAE, Saudi Arabia and wider GCC.
Quality SystemsISO 13485 · ISO 14971
Quality Systems & ComplianceQMS design, implementation and remediation; ISO 13485, ISO 14971, IEC 62304, QMSR, audit support, internal audits, CAPA, supplier controls and compliance-readiness support.
MDSAPMulti-market QMS audit
MDSAP ReadinessPreparation for a single regulatory audit accepted across participating markets, including the United States, Canada, Australia, Brazil and Japan.
Digital Health & AISaMD · AI · Cybersecurity
Digital Health & AISaMD & AI regulatory strategy, software lifecycle compliance, cybersecurity - ISO 27001, and data privacy & protection. Support for GDPR, UK GDPR, HIPAA, PIPEDA, Swiss FADP, UAE & Saudi PDPL, ICT Health Data, and EU AI Act compliance.
Clinical EvidenceValidation · Performance
Clinical & Performance EvidenceClinical evaluation, performance validation, evidence planning, study strategy and documentation aligned with the intended purpose and target markets.
Post-MarketPMS · Vigilance
Post-Market SurveillancePost-market surveillance, vigilance, complaint handling, trend reporting, corrective actions and lifecycle regulatory maintenance.
Wellness Product ReadinessGlobal market strategy
Wellness Product Regulatory ReadinessGlobal classification and market-positioning support for wellness products, including claims and labelling review, evidence expectations and market-entry planning across the UAE, EU, US, UK and other priority markets.
GLOBAL MARKETS, REGULATORY FRAMEWORKS & STANDARDS
EU MDR
EU IVDR
CE Marking
UKCA
US FDA
FDA 510(k)
MDSAP
ISO 13485
ISO 14971
IEC 62304
IEC 62366
MOHAP
SFDA
UAE & GCC
SaMD & AI
GDPR
HIPAA
PDPL
Client Feedback

Trusted by regulatory & quality leaders

Real feedback from MedTech, Pharma and HealthTech teams across regulatory, quality and market-access requirements in the EU, US, UK and GCC.

"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."

Klaudia ChoCEO, 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."

Laura TowartFounder & CEO, 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."

Jordan PollackCo-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 ISO 13485, EU MDR, U.S. FDA, UK MHRA, MDSAP, GDPR, HIPAA, and DICOM compliance. We value their professionalism, responsiveness, and regulatory expertise."

Mads FiigCEO, Brainreader A/S

"Compliance MedQRA has been a trusted partner throughout our compliance journey. Their deep expertise in health data compliance and PDPL, combined with a highly structured approach, has provided us with clear direction and confidence at every stage. Their professionalism and attention to detail have made working with them a truly valuable experience."

Iman Chehade & Sally MaddahCo-Founders, Hiya Health Care

"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."

Klaudia ChoCEO, 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."

Laura TowartFounder & CEO, 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."

Jordan PollackCo-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 ISO 13485, EU MDR, U.S. FDA, UK MHRA, MDSAP, GDPR, HIPAA, and DICOM compliance. We value their professionalism, responsiveness, and regulatory expertise."

Mads FiigCEO, Brainreader A/S

"Compliance MedQRA has been a trusted partner throughout our compliance journey. Their deep expertise in health data compliance and PDPL, combined with a highly structured approach, has provided us with clear direction and confidence at every stage. Their professionalism and attention to detail have made working with them a truly valuable experience."

Iman Chehade & Sally MaddahCo-Founders, Hiya Health Care
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