STRATEGY
Regulatory Strategy & Market Access
Classification, regulatory pathways and market-entry planning across the EU, US and UAE/GCC.
Expert support
QA/RA consulting alongside eQMS (QraOne)
For teams that need more than software, Compliance MedQRA provides hands-on regulatory and quality support across key markets and quality-system activities.
End-to-end regulatory & quality support.
SUBMISSIONS
Technical Documentation & Submissions
Hands-on support with technical files, GSPR, evidence strategy, FDA submissions and authority responses.
QMS
QMS, Audits & Remediation
ISO 13485 QMS design, SOPs, internal audits, mock inspections, CAPA and remediation support.
DIGITAL HEALTH
SaMD, AI & Digital Health
Regulatory support for software and AI-enabled products, including lifecycle, risk and software documentation.
LIFECYCLE
Risk & Post-Market Compliance
Risk management, PMS, PMCF, complaint handling, vigilance, trend reporting and lifecycle compliance.
EXTENDED TEAM
Fractional QA/RA & Compliance Support
Flexible expert capacity for growing teams, including QA/RA leadership, privacy and regulatory training.
