RQM+ provides deep regulatory and clinical expertise for in vitro diagnostic (IVD) manufacturers, with fully integrated support across EU IVDR and U.S. FDA requirements. From strategic planning through post-market performance follow-up (PMPF), our MedTech-only team helps de-risk development, accelerate submissions, and support global market success.
Why RQM+ for IVDs?
-
MedTech-Only CRO
100% focused on medical devices, diagnostics, and combination products.
-
Regulatory and Clinical Integration
End-to-end alignment across regulatory strategy, clinical performance, and market access.
-
True IVDR Experts
Scientific validity, classification, PERs, and compliance with Annexes I, XIII, and XIV.
-
FDA Compliance
U.S. regulatory strategy aligned with 21 CFR Parts 807, 809, 812, 820, and more.
-
Life Cycle Support
From design through post-market surveillance and notified body audits.
Standards We Navigate
-
EU IVDR (Regulation EU 2017/746)
-
ISO 13485 – Quality Management Systems for Medical Devices
-
ISO 15189 – Medical Laboratories – Requirements for Quality and Competence
-
ISO 20916 – Clinical Performance Studies of IVDs
-
FDA 21 CFR Parts 11, 50, 56, 58, 807, 809, 812, 820
-
CLSI EP Series Guidelines (e.g., EP05, EP07, EP09)
-
GDPR and IVDR Article 61 – Data protection in EU clinical research
IVD Support Across the Total Product Life Cycle
Expand each to see key services.
Flexible Partnering Solutions
Full-Service Outsourcing
End-to-end project ownership, from strategy to execution. Our managed outsourcing solutions enable easy collaboration, streamlined operations, and expert oversight so you can focus on what you do best.
Professional Consulting
Industry-leading MedTech consultants with the strategic insight and regulatory expertise to solve your toughest challenges. Our global team stays ahead of evolving regulations to keep your innovations moving forward.
Professional Staffing
Need an expert or a full team? We provide highly qualified MedTech professionals who integrate quickly and easily into your organization — the right people, right when you need them.