Regulatory strategy & classification
Intended-purpose review, device qualification and classification, regulatory pathway planning and conformity-assessment strategy for UK, EU and international markets.
Medical device consultancy
Complete support from regulatory strategy to post-market compliance.
RHQC provides practical, end-to-end support across the full medical device lifecycle—for individual deliverables, major certification programmes or an outsourced regulatory function.
More than advice. Documentation that is ready to use.
RHQC can create the complete technical documentation dossier, review an existing file or close specific evidence gaps. Work is developed around the device, its classification, risk profile and target markets.
Experience spans Class I through Class III, including sterile devices, implantables, reusable and single-use instruments, wound care, procedure packs and substance-based products.
Complete technical documentation dossiers
Creation, remediation and review of complete technical files, including device description, design and manufacturing information, GSPR evidence, verification and validation, labelling and declarations.
Clinical evaluation
Clinical evaluation plans and reports, literature searches, equivalence assessment, state-of-the-art review, benefit-risk conclusions and Article 61 evidence strategies.
Biological evaluation
BEPs and BERs aligned with ISO 10993, including endpoint strategy, test justification, toxicological considerations and integration with risk management.
Risk management & usability
ISO 14971 risk management files, benefit-risk evaluation, production and post-production links, usability engineering and supporting compliance evidence.
Sterilisation, packaging & shelf life
Review and coordination of sterilisation validation, bioburden and microbiological evidence, sterile barrier packaging, transportation and shelf-life qualification.
Labelling, UDI & declarations
Artwork and IFU review, symbols, language strategy, UDI requirements, implant cards, economic-operator details and declarations of conformity.
PMS, PMCF & vigilance
PMS plans and reports, PMCF, PSURs, trend reporting, complaints, vigilance, FSCA support and lifecycle compliance.
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