Remote, scalable, and highly cost-effective RA/QA services delivered by seasoned professionals — audit-ready, fully compliant, just-in-time.
RQM³ was established by a group of MedTech regulatory, quality, and clinical professionals for the purpose of providing a comprehensive regulatory and quality umbrella for MedTech companies.
In today's global market, regulatory affairs and quality assurance have become significant operational hurdles, demanding a high level of professionalism to meet continuously evolving international requirements.
As an intelligent Regulatory Affairs and Quality Assurance platform, RQM³ solves this exact challenge by delivering a highly professional, "just-in-time" response and feedback from seasoned and experienced RA/QA managers.
We provide remote, scalable, and highly cost-effective services in full compliance with critical legislative frameworks, including ISO 13485:2016, FDA QSR, FDA QMSR, EU MDR 2017/745, EU IVDR 2017/746, EU Legacy Directives, and MDSAP. By bridging elite human expertise with intelligent digital infrastructure, RQM³ ensures your market access is secure, fully compliant, and audit-ready, without the traditional overhead.
Decades of combined experience across regulatory affairs, quality assurance, and clinical operations.
We stay ahead of evolving requirements across all major regulatory jurisdictions worldwide.
Scalable engagement model — access senior RA/QA professionals exactly when you need them.
End-to-end support across the full MedTech product lifecycle, from design controls to post-market surveillance.
Design, implementation, and maintenance of ISO 13485-compliant QMS tailored to your organization's size and product portfolio.
Strategic regulatory planning and preparation of technical documentation for FDA, EU, and international market registrations.
Full support for EU MDR 2017/745 and IVDR 2017/746 compliance, including clinical/analytical evaluation, PMS, and Notified Body interactions.
Systematic risk management processes in line with ISO 14971, covering hazard identification, risk evaluation, and mitigation strategies.
Ongoing PMS programs, vigilance reporting, complaint handling, and FSCA/FSN management to maintain market access.
Comprehensive audit preparation, gap analysis, mock inspections, and corrective action management for FDA and Notified Body audits.
Clinical strategy and planning: Clinical plans, investigator's brochures, Informed Consent, CRF, CEP/CER, PMCF, and incident reporting.
RA/QA training programs and on-demand strategic consulting tailored to your team's needs and regulatory environment.
Regulatory and clinical due diligence, non-conformity remediation, startup to enterprise support, and flexible remote, scalable engagement models.
A structured, collaborative methodology that integrates seamlessly with your organization.
We evaluate your product, target markets, and classification to define the optimal regulatory strategy from the outset.
Comprehensive submission solicitation and regulatory agency interaction support.
We build or improve quality management systems that are audit-ready, scalable, and aligned with international standards.
Continuous monitoring of regulatory updates, post-market activities, and vigilance reporting to maintain compliance.
Tangible benefits that translate directly into faster time-to-market, reduced risk, and sustainable growth.
Access regulatory and quality expertise on-demand — without the overhead of a full in-house team. Scale up or down based on your project needs.
Our deep regulatory knowledge and established frameworks accelerate your submission timelines and approval processes across all major markets.
Stay ahead of regulatory and quality requirements. We monitor evolving requirements and proactively adapt your systems.
Proactive identification and mitigation of compliance risks before they become issues — protecting your business and patients.
Comprehensive coverage across FDA, EU, and international regulatory frameworks so you can pursue multiple markets simultaneously.
A curated team of seasoned RA/QA professionals with deep domain knowledge and established relationships with regulatory bodies.
We maintain deep expertise across all critical frameworks — and other standards and legislations.
Medical devices quality management systems
Quality System Regulation (21 CFR Part 820)
Quality Management System Regulation
European Medical Device Regulation
European In Vitro Diagnostic Regulation
Legacy European medical device directives
Medical Device Single Audit Program
Risk management for medical devices
Usability engineering for medical devices
IEC 60601-X-XX, IEC 62304, and other applicable product-specific standards
Ready to simplify your regulatory journey? Our team of seasoned RA/QA professionals is here to provide the expert guidance your MedTech company needs.