Your product changes.
Your evidence must keep up.
WHPL helps Regulatory, Clinical/Medical, PMS/Vigilance and Quality/Risk teams keep claims, evidence, safety conclusions and lifecycle artifacts traceable, consistent and impact-aware across MDR and IVDR obligations.
Evidence fragmentation becomes regulatory debt.
Regulatory experts should apply judgment—not spend their time acting as human integration middleware across documents, systems and functions.
The same product can carry different conclusions.
Claims, incidence rates, risk positions and benefit-risk conclusions can diverge across CER/PER, PMS, PSUR, PMCF/PMPF and risk artifacts.
One new signal can trigger many reviews.
A complaint trend, publication, study result or product version may affect multiple claims, risks and regulated outputs.
Substantiation is repeatedly reconstructed.
Teams lose time locating the exact supporting evidence, rationale and source chain behind a claim or conclusion.
A shared evidence layer for the teams responsible for the product lifecycle.
Regulatory Affairs
Change impact, traceability, readiness and cross-functional regulatory control.
Clinical / Medical Affairs
Continuous evidence evaluation, literature, PMCF/PMPF and claim substantiation.
PMS / Vigilance
Signal-to-risk-to-evaluation propagation and evidence-based escalation.
Quality / Risk
Connections between controls, post-market findings and clinical/performance conclusions.
The evidence-control layer for regulated medical products.
Use one common evidence model to connect MDR clinical evidence and IVDR performance evidence to risk, post-market intelligence and lifecycle regulatory outputs—without replacing every system of record.
See How Continuous Evidence Control Works →Start with one product family and expose the evidence gaps.
An Evidence Integrity Assessment maps sources, recurring artifacts, contradictions, stale conclusions and downstream change-impact requirements before a bounded pilot.