Service Definition
A technology-enabled service that keeps every marketed device continuously compliant, so clinical evidence and post-market safety obligations are met on cadence rather than rebuilt under deadline.
Last updated 21 August 2026
Evidence Assist maintains an uninterrupted clinical evaluation and post-market surveillance cycle for each covered device. Every cycle follows the same loop. Data is compiled from the manufacturer’s systems, the evidence landscape is monitored, findings are evaluated against defined acceptance criteria, and submission-ready documents are delivered.
All work is performed by qualified clinical reviewers inside the Evidence Cloud platform, which serves as the single system of record and builds the audit trail as the work happens. The service is delivered under a fixed annual fee per device.
Maintains the clinical evaluation. Keeps the Clinical Evaluation Report current, the state of the art re-established, and every claim supported by evidence that has been searched, appraised and documented.
Revised, signature-ready Clinical Evaluation Reports issued on the device’s required cadence, consistent with the same cycle’s surveillance results, and built and reviewed by a qualified clinical reviewer.
Systematic searches, screening and appraisal of newly published evidence on the device and on equivalent devices, evaluated against the relevant acceptance criteria in accordance with Annex XIV Part B and MDCG 2020-7. Full search proof of work is retained, including databases, terms, dates and screening decisions.
Re-execution of the systematic literature search, confirmation or revision of the state of the art narrative, and review of acceptance criteria in accordance with Annex XIV Part A and MDCG 2020-6, reported per clinical group with changes flagged.
Every claim is kept supported, with performance re-checked against its own acceptance criteria as new evidence appears. Provides a claims status report covering deviations, contradictory evidence and weakening support.
Substantiation review of promotional and marketing claims against the clinical evidence, maintained in an evidence-backed claims register. Supports defending existing claims under scrutiny and identifying new claims the evidence now supports, in accordance with MDR Article 7.
Full-text access to the journals and databases the evidence depends on, sourced through existing subscriptions and document-delivery services so screening and appraisal are never delayed. Maintains a single deduplicated reference library across the portfolio and keeps article reuse within the terms of the manufacturer’s copyright licences.
A qualified reviewer meeting notified body expectations performs all clinical evaluation documentation updates and acts as signatory where required.
Runs post-market surveillance. Monitors the safety landscape, triages incoming complaints and cases, compiles manufacturer-collected data, and produces the periodic reports the regulation requires.
Ongoing monitoring of designated safety and vigilance databases, including FDA MAUDE, TPLC, recall databases and EU vigilance sources, covering the device and designated similar devices in support of post-market surveillance under Articles 87 and 88. Alerts and automated findings reports are issued as events arise.
Consolidated reporting across vigilance and literature sources covering events, complications and complaints for the device and similar devices, including adverse-event review and write-up, trend analysis, and full search proof of work.
Complaints and cases sync continuously. Reportable findings are flagged for escalation under existing procedures, and the remainder are routed into post-market surveillance and post-market clinical follow-up.
Periodic Safety Update Reports and PMCF Evaluation Reports prepared on the required cadence, consistent with the same cycle’s surveillance results and delivered signature-ready.
Manufacturer-collected follow-up data, including user surveys, usage logs, performance telemetry and complaint trends, assembled into the evaluation and assessed against the relevant acceptance criteria.
Direct integration to the customer relationship management system and related environments, so complaint and sales data flow automatically with no manual export, structuring or upload. Cleanup and normalisation are included.
Three capabilities support the clinical and safety lines together rather than belonging to either one.
Support during notified body or competent authority review, including end-to-end traceability, audit-ready documentation on request, and drafted responses to evidence-related questions arising from conformity assessment.
Monitoring of the regulatory landscape applicable to the covered devices, including MDCG guidance, notified body positions, FDA guidances, predetermined change control developments, EU AI Act implementing measures and relevant standards, with a device-level impact assessment and recommended actions.
All work is carried out in Evidence Cloud, giving a single system of record across the portfolio, unlimited users, and a submission-ready audit trail that is produced as a by-product of the work itself.
Continuous by design. Evidence maintained continuously stays audit-ready at all times. The alternative, leaving a file untouched for eighteen months and rebuilding it in a single sprint against a deadline, is both more expensive per unit of work and materially riskier, because the backlog is reconciled under time pressure and any slip becomes a certificate problem.
Evidence Assist and Evidence Cloud are services of CiteMed. Scope is defined per device in the applicable agreement.