RQM+

End-to-End MedTech Regulatory, Quality, and Clinical Services

RQM+ is a global medtech service provider that delivers comprehensive regulatory, quality, and clinical solutions across the entire lifecycle of medical devices, in vitro diagnostics (IVD), and combination products. Formed through strategic mergers of leading regulatory and clinical consultancies (such as Regulatory Quality Solutions and Maetrics), the firm supports companies ranging from early-stage venture-backed startups to global enterprise healthcare manufacturers.

Core Execution Pillars & Capabilities

• Regulatory Strategy & Submissions: Guiding global market access pathways, including U.S. FDA submissions (510(k), PMA, De Novo, IDE) and European Union IVDR/MDR technical documentation and CE mark compliance.
• Quality Management Systems (QMS): Designing, implementing, and auditing ISO 13485 and FDA QSR-compliant management systems, alongside remediation support for warning letters or audit findings.
• Clinical Trial & Contract Research Organization (CRO) Services: Operating as a full-service CRO focused specifically on medtech, managing clinical trial design, execution, patient recruitment, and post-market clinical follow-up (PMCF) studies.
• Post-Market Surveillance & Biocompatibility: Managing vigilance reporting, risk management (ISO 14971), post-market performance monitoring, and chemical characterization assessments.