Evidence fragmentation
Clinical, Regulatory, Quality and Post-Market teams can work from different evidence, conclusions and controlled artifacts.
WHPL Continuous Product Evidence System
Continuous Evidence Integrity for Regulated Medical Products.
Know what changed, what it affects and what evidence action is required—across clinical and performance evidence, risk, PMS, PMCF/PMPF, CER/PER and product changes.
Source-linkedTraceableHuman-controlledImpact-aware
CONTINUOUS PRODUCT EVIDENCEOne evidence-control layer. Every impacted relationship visible.
NEW CHANGEComplaint · study · product versionImpact propagates across connected evidence
PRODUCTDevice · variant · version
CLAIMSClinical · performance · safety
EVIDENCEStudies · literature · RWE
WHPL CPESProduct EvidenceTrace · reconcile · assess impact
SAFETY & RISKHazards · controls · benefit-risk
POST-MARKETPMS · complaints · vigilance
REGULATED OUTPUTSCER/PER · PSUR · SSCP/SSP
Source-linkedReviewableHuman-controlled
The operating problem
Regulatory evidence does not live in one document.
A claim can appear across evaluation reports, risk files, post-market outputs, labelling and public safety information. As products and evidence change, keeping those conclusions aligned becomes a continuous regulatory operation.
Repeated reconciliation
Each CER/PER, PSUR or PMCF/PMPF update can start another manual search, comparison and reconciliation exercise.
Hidden change impact
A new complaint, publication, study result or product version can make existing claims, risks and conclusions stale.
Why documents are not enough
One evidence layer across the product lifecycle.
WHPL connects product claims, clinical/performance evidence, risks, post-market signals and regulated outputs into a traceable evidence model—so teams can identify inconsistencies, gaps and downstream impact before the next review.
Product→Claim→Evidence→Risk→PMS / PMCF / PMPF→CER / PER→Change impact
How the system works
Detect change. Assess impact. Route controlled action.
The workflow operates above existing systems of record and preserves expert review at each regulated decision point.
01IngestSystems · files · evidence02NormaliseControlled evidence objects03ConnectClaims · sources · risks04ReconcileFacts · metrics · conclusions05Detect changeNew evidence or product state06Assess impactAffected dependencies07Route actionHuman review & approval
What the product connects
Relationships—not a collection of independent modules.
Move from any claim or conclusion to its supporting source, rationale, risk context, post-market signal and regulated output.
MDR and IVDR evidence packs
One evidence layer. Two regulatory packs.
MDR clinical evidence and IVDR performance evidence run on the same evidence-control architecture while retaining their distinct regulated outputs.
Clinical evidence continuity
Clinical Evaluation Plan / CERPMS Plan & Report / PSURPMCF Plan & Evaluation ReportClinical Investigation evidenceRisk · SSCP · Claims · Benefit-Risk
Performance evidence continuity
Performance Evaluation Plan / PERPMS Plan & Report / PSURPMPF Plan & Evaluation ReportScientific validity · Analytical & Clinical PerformanceRisk · SSP · Claims · Benefit-Risk
Evidence-grounded intelligence
AI that can show its evidence.
Agents operate on traceable evidence and propose reviewable actions. They do not replace accountable regulatory judgment.
Consistency Agent
Detect contradictory facts, claims, risks and conclusions across controlled artifacts.
Evidence Gap Agent
Identify claims and conclusions with weak, stale or missing support.
Change Impact Agent
Map downstream consequences of a product, evidence or safety change.
PMS Signal Agent
Surface complaint, vigilance and post-market patterns requiring review.
Literature Agent
Assess new external evidence against current claims and conclusions.
Regulatory Readiness Agent
Highlight unresolved dependencies before review, submission or audit.
Controlled Drafting Agent
Prepare source-grounded proposed updates after impact assessment and under reviewer approval.
TRACEABLE · EVIDENCE-GROUNDED · HUMAN-CONTROLLED
Every insight remains source-linked, reviewable and subject to controlled change and approval.
Work above—not instead of—your existing stack
Add evidence control without forcing system replacement.
EXISTING SYSTEMSQMSRIMEDCPLMComplaint systemsDocument repositories
→WHPL CPESEvidence relationships + change impact
→CONTROLLED OUTCOMESFaster reconciliationBetter traceabilityFewer stale conclusionsAudit readiness
Built for cross-functional evidence control
One shared evidence model. Role-specific outcomes.
Know what must be reviewed.
Change impact, traceability, readiness and cross-functional regulatory control.
Defend every claim.
Continuous evidence evaluation, literature, PMCF/PMPF and claim substantiation.
Propagate signals responsibly.
Connect post-market findings to risk, benefit-risk and clinical/performance evaluation.
Keep risk conclusions current.
Link controls, post-market findings and clinical/performance evidence.
Recommended starting point
Request an Evidence Integrity Assessment →Request an Evidence Integrity Assessment.
Review one product family to map evidence sources, recurring artifacts, major gaps, contradictions and reconciliation points—then choose a bounded pilot with measurable outcomes.