Comprehensive Literature Review Services

Every regulatory submission, safety report, and value dossier stands on the literature behind it. A systematic literature review builds that foundation: identifying, screening, and synthesizing the published evidence with the rigor and transparency regulators and HTA bodies expect.

MadeAi runs the entire review in one workflow, protocol through report: AI moves at machine speed through search, screening, and extraction, while subject matter experts validate every call that matters. The result: a PRISMA-aligned, audit-ready review in weeks, not months. And with living SLRs, new publications flow in continuously, so downstream documents update instead of restarting.

Systematic literature reviews are commonly used for:

• Building the evidence base for regulatory submissions
• HTA, GVD, and payer evidence packages
• PRISMA-compliant, publication-grade reviews
• Continuous evidence monitoring between cycles

Under EU MDR, the Clinical Evaluation Report is where a device’s clinical story gets judged. Notified bodies expect a documented state-of-the-art review, a defensible equivalence strategy, and a benefit–risk narrative where every claim traces to appraised evidence.

MadeAi builds Clinical Evaluation Plans and Reports on a traceable review engine aligned with EU MDR expectations, so every claim is source-linked from the start and each update cycle refreshes a living foundation instead of rebuilding from a blank page. Notified body questions become answers, not scrambles.

CER / CEP support is commonly used for:

• Identifying emerging patient concerns and unmet needs
• Understanding real-world treatment experiences
• Monitoring patient sentiment and therapy perception
• Detecting trends in disease discussions and support communities

U.S. clearance and approval run on clinical evidence: substantial equivalence for 510(k), safety and effectiveness for PMA. The published literature carries much of that argument, and FDA expects it assembled with systematic rigor.

MadeAi delivers predicate device literature reviews, evidence syntheses, and gap analyses that reveal where the published record supports your claims, and where it doesn’t, while there’s still time to act. And because it’s built on one foundation, your U.S. narrative stays perfectly in step with your EU submissions.

510(k) / PMA evidence support is commonly used for:

• Predicate device literature reviews
• Safety & effectiveness evidence synthesis
• Evidence gap analysis before submission
• Consistency across FDA and EU MDR narratives

Post-market surveillance never stops. Every PSUR cycle demands a fresh, documented view of the safety literature, and teams that restart the search from zero each period lose weeks to work already done.

MadeAi turns the PSUR into an update instead of a rebuild. Continuous literature surveillance captures safety-relevant findings the moment they publish: screened, deduplicated, and fully traceable. Every report lands on schedule, always in step with your CER and PMCF evidence.

PSUR support is commonly used for:

• Periodic safety update reporting under EU MDR
• Continuous safety literature surveillance
• Benefit–risk updates aligned with the CER
• PMCF plans and reports from the same foundation

When healthcare professionals ask about a product, fast isn’t enough. Medical information teams must deliver answers that are accurate, compliant, and consistent with everything the regulatory documents already say. Every single time.

MadeAi delivers timely, evidence-based Medical Information Responses with full citation linkage: standard response letters and custom documents, drawn from the same screened and appraised foundation as your submissions. The field never contradicts the file, no matter how many queries come in.

Medical Information Responses are commonly used for:

• Standard response letters (SRLs)
• Custom responses to unsolicited HCP queries
• Citation-linked, compliance-ready documentation
• Narrative consistency with regulatory documents