Clinical evaluation evidence that stands up to audit
Build and maintain CER-grade literature evidence in a repeatable workflow, so traceability is built from the first search and the evidence is ready when a notified body asks for it.
- Clinical Evaluation Manager CER updates, SOTA reviews, and evidence-gap coverage.
- Regulatory Affairs Defensibility, audit readiness, and notified-body responses.
- Medical Writer · CER Evidence tables, reconciliation loops, and drafting burden.
Under MDR, the evidence has to be defensible, and it has to stay current
Clinical evaluations and post-market surveillance require systematic, repeatable literature appraisal that an assessor can follow end to end. Manual processes turn every update into a fresh project and leave every judgment hard to reconstruct months later.
- CER literature appraisal repeated from scratch each cycle
- Post-market evidence reviews hard to keep current
- Appraisal rationale not reconstructable later
- Audit preparation that consumes the team
Spend less time preparing for audits. Be confident the evidence will hold up
Faster CER cycles
Your search, screening, and appraisal follow one repeatable process, so each clinical evaluation cycle costs less time and ends in a result you can trust.
The right appraisal for every study
Each study is routed to the appraisal approach that fits it, whether RoB 2, ROBINS-I, or a structured Evidence Profile.
Post-market without the rebuild
When the literature moves, you re-run the review instead of starting over. Provenance keeps each update traceable, making ongoing surveillance manageable.
Audits stop being a scramble
Every judgment links to the exact supporting passage, so when an assessor asks why, the answer is one click away.
- MDR / CER-ready workflow
- RoB 2 / ROBINS-I support
- Source-grounded outputs
- Reviewer-controlled decisions
- Traceable update history
Systematic review teams
PRISMA-ready reviews with the audit trail built as you work, and appraisal consistency that holds whether one reviewer or ten screen.
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Pharma / HEOR / evidence strategy
SLRs and evidence landscapes with submission-grade appraisal consistency. Payer narratives that trace to source on demand.
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Academic researchers
Rigorous reviews with methodology transparent enough to publish. Every conclusion traces to its source paper, page, and quote.
ExploreTalk to us about your CER workflow
Book a workflow demo and we will walk through traceability and post-market use with your team.
A free plan is available, no card required