Company description

RQM+ is a global MedTech services provider specialising in regulatory, quality, clinical and laboratory solutions for medical device and diagnostics companies. The company acts as a full-service partner across the entire product lifecycle, supporting organisations from early product development through to market access and post-market compliance.

With roots dating back to the 1980s and the formation of Regulatory and Quality Solutions in 2008, RQM+ has grown through strategic acquisitions and expansion to become one of the largest specialist consulting organisations serving the medical technology sector. The company works with a wide range of clients, from start-ups to multinational manufacturers, helping them navigate complex global regulatory frameworks and accelerate time to market for innovative technologies.

RQM+ combines regulatory strategy, clinical development expertise, analytical laboratory capabilities and reimbursement consulting to provide integrated support across the product lifecycle. Its teams include former regulators and industry specialists who provide guidance on global compliance requirements, quality systems and clinical evidence generation for medical devices, in vitro diagnostics and combination products.

Operating across North America and Europe, the company aims to simplify the complex pathway from concept to patient access by aligning regulatory strategy, scientific testing and commercial considerations. Through this integrated approach, RQM+ helps MedTech innovators reduce development risk, streamline regulatory approvals and bring safe and effective technologies to market more efficiently.

Key products and services

Regulatory and quality consulting

• Regulatory strategy and submissions for FDA, EU MDR/IVDR and other global authorities

• Quality system development and remediation

• Compliance audits and regulatory readiness support

• Design assurance, verification and validation services

Clinical trial services

• Clinical trial design and management

• Early feasibility and first-in-human studies

• Clinical evaluation reports and post-market studies

• Data management and operational support for device trials

Laboratory and material science services

• Chemical characterisation and extractables & leachables (E&L) testing

• Biocompatibility and toxicology assessments

• Failure analysis and investigative testing

• Analytical testing for regulatory submissions through its Jordi Labs facilities

Reimbursement and market access

• Health economics and reimbursement strategy

• Coding and coverage support

• Market access planning aligned with regulatory and clinical evidence

Integrated lifecycle support

• End-to-end MedTech product development support from concept to post-market surveillance

• Consulting, outsourcing and staff augmentation models tailored to client needs

By combining regulatory expertise, clinical research capabilities and advanced laboratory testing within a single integrated model, RQM+ positions itself as a strategic partner for the MedTech industry. The company’s lifecycle approach enables device and diagnostics manufacturers to navigate regulatory complexity, generate the required clinical and scientific evidence, and achieve successful global market access for innovative healthcare technologies.