IVD qualification & classification
Device qualification, intended purpose and classification under IVDR, including self-testing, near-patient testing and associated regulatory strategy.
IVD consultancy
IVDR compliance made practical.
Regulatory, quality and performance-evaluation support for IVD manufacturers, distributors and importers navigating the transition to more demanding evidence and oversight.
Clear structure for a demanding regulatory framework.
RHQC supports IVD projects from intended-purpose and classification decisions through technical documentation, performance evaluation, QMS and market entry.
Support can address one defined gap or coordinate the complete compliance programme.
IVDR gap assessment & transition
Structured review of legacy IVDD files, QMS and evidence against current IVDR requirements, with prioritised remediation planning.
IVD technical documentation
Creation and review of complete Annex II and III technical documentation, including device description, design, manufacture, GSPR evidence, labelling and post-market documentation.
Performance evaluation
Performance evaluation planning and reporting, scientific validity, analytical performance, clinical performance and post-market performance follow-up.
ISO 13485 for IVD organisations
QMS implementation, integration and maintenance tailored to IVD manufacturers, including notified body readiness and ongoing compliance.
IVD market access
UK and EU registrations, economic-operator requirements, labelling strategy and coordination with authorised representation or local partners where required.
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