Complex regulation.
Clear direction.
RHQC Ltd provides comprehensive regulatory, quality and market-access support across medical devices, IVDs and wider product compliance—from technical documentation and quality systems to auditing, training and global market entry.
One consultancy. Complete support.
Regulatory depth without the consultancy layers.
RHQC supports manufacturers, importers and distributors from initial regulatory planning through to certification, registration and ongoing compliance.
Clients work directly with experienced senior leadership, combining the continuity and responsiveness of a family-founded business with the technical capability required for complex international projects.
Services
Support built around the full product lifecycle.
Engage RHQC for a defined project, independent review or ongoing outsourced regulatory and quality function.
Medical device consultancy
Complete regulatory support from classification and strategy to full technical documentation, certification and post-market compliance.
Explore service ↗02IVD & IVDR compliance
IVDR transition, performance evaluation, technical documentation, QMS integration and market-entry support for in vitro diagnostic devices.
Explore service ↗03QMS & certification
Creation, implementation and maintenance of ISO 13485, ISO 9001 and other applicable quality management systems.
Explore service ↗04Internal & external auditing
Independent process, system and supplier audits, certification readiness, CAPA support and retained audit programmes.
Explore service ↗05UK Responsible Person
A trusted UK regulatory presence for overseas manufacturers, including MHRA registration, document verification and ongoing compliance.
Explore service ↗06Global market access
Coordinated regulatory preparation for markets worldwide, supported by trusted in-market representation partners where required.
Explore service ↗07PRRC & retained support
PRRC representation and flexible retained consultancy across the full regulatory lifecycle, integrated with your quality and regulatory systems.
Explore service ↗08Product compliance
Technical and regulatory support for general products, toys, cosmetics, REACH and wider consumer-product requirements.
Explore service ↗09Professional training
Documented, practical training tailored to your products, procedures, regulatory responsibilities and internal competence needs.
Explore service ↗Capability in practice
From everyday devices to the highest-risk Class III products.
RHQC has supported certification and market access across Class I, Is, Im, Ir, IIa, IIb and Class III medical devices, as well as IVDs.
Experience includes full technical documentation dossiers, clinical and biological evidence, sterile devices, reprocessing, implantables, surgical instruments, wound care, procedure packs and post-market systems.
Broad device and risk-class experience
Major-market strategy with local representation partners
From concept and QMS to post-market compliance
Established in 2007
Family-founded.
Internationally focused.
RHQC Ltd delivers the personal accountability of an independent consultancy with the regulatory range of a larger firm. Advice is practical, direct and shaped around the client—not a standard package.
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