RQM+ Auditor Profile

RQM+ is a regulatory compliance consulting firm with offices in Dubai and Washington, DC, specializing in medical device regulatory compliance, healthcare technology, and life sciences. The firm bridges the gap between Middle Eastern and US regulatory requirements, serving organizations that need to navigate complex multi-jurisdictional compliance landscapes.

What RQM+ Does Well

Medical device regulatory expertise is the firm's core differentiator. RQM+ understands the regulatory pathways for medical devices across FDA, EU MDR, and Gulf Cooperation Council requirements. This niche specialization is rare and valuable for medtech companies.

Cross-jurisdictional capability with presence in both the UAE and the US positions RQM+ uniquely for organizations that need to comply with both regional and international regulatory requirements. Medical device companies selling into Middle Eastern and US markets benefit from this dual perspective.

Information security for healthcare combines ISO 27001 and HIPAA expertise with medical device regulatory knowledge. As connected medical devices become more prevalent, the intersection of cybersecurity and medical device regulation is increasingly important.

Service Offerings

• ISO 13485 certification support — Quality management for medical device manufacturers
• ISO 27001 implementation and audit support — Information security for healthcare technology
• FDA regulatory submissions — 510(k), PMA, and other US regulatory pathways
• EU MDR compliance — European medical device regulation compliance
• HIPAA assessments — Healthcare data protection compliance
• Gulf regulatory compliance — Regional medical device registration and compliance

Who Should Choose RQM+

Medical device manufacturers, healthcare technology companies, and life sciences organizations operating in the Middle East, US, or both will find RQM+ a uniquely positioned compliance partner. Organizations at the intersection of medical device regulation and information security benefit most from the firm's specialized expertise.