Resources · Regulatory

Regulatory & clinical documentation.

510(k) summaries, CE Mark declarations, IFU, and product manuals, the documentation pharma and clinical buyers need before procurement.

USA Under review

FDA 510(k) clearances

Cleared product summaries across LiverMultiScan, CoverScan, MRCP+, and Hepatica.

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EU Under review

CE Mark, Class IIa

Conformity declarations under MDR for all clinical products.

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UK

UKCA conformity

UK Conformity Assessment documentation for NHS procurement.

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Quality Under review

ISO 13485

Quality management system certification covering all products and services.

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Pharma BQP Under review

FDA Biomarker Qualification

Active engagement in the FDA Biomarker Qualification Programme for cT1.

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Product Manuals

Product manuals & IFU

Instructions for Use, technical specifications, and operator manuals.

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Customer

Perspectum Portal

Existing customers, access reports, results, and account documentation.

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Trust

Compliance & Trust Centre

Security posture, data handling, and patient privacy controls.

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Cards tagged Under review describe clearances or programme status that has not yet been checked against the RA Claims Matrix. Where a document is listed, request it from the team; availability depends on the market. Request a change ↗

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If you can’t find what you’re after, a specific case study, a regulatory document, a slide deck, ask the team directly.

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