Post-Market Evidence
From PMS and PMCF to registries and real-world follow-up, we help manufacturers generate the evidence needed to support compliance, benefit-risk confidence, and sustained market access.
Building Defensible Evidence Beyond Approval
Post-market evidence is not just a reporting obligation. It is a continuous evidence strategy that helps manufacturers demonstrate ongoing safety, performance, and clinical relevance across the product lifecycle.
Our approach integrates PMS, PMCF, complaints, feedback, literature, and real-world performance data into a structured post-market evidence framework. As equivalence pathways become more restrictive under EU MDR, we help manufacturers build their own defensible evidence base to support benefit-risk evaluation, technical documentation updates, and sustained market approval.
By bringing IQA Biometrics into the process early, we transform emerging safety signals into structured, actionable insights. This enables meaningful risk evaluation, supports efficient reporting, reduces unnecessary field actions, and helps manufacturers protect both compliance and market confidence
Key Compliance Outcomes
Collect and structure post-market data from multiple sources.
Track safety and performance across the lifecycle.
Support PMS Reports, PSURs, and technical updates.
Identify and address clinically meaningful risks early.
Capabilities That Strengthen Post-Market Evidence
We support medical devices and IVDs with the clinical, regulatory, analytical, and operational capabilities needed to generate defensible post-market evidence across the product lifecycle.
Post-Market Surveillance & Signal Management
- Design PMS strategies, monitor emerging signals, analyze trends, and support structured safety oversight across the lifecycle.
PMCF & Performance Evidence
- Build PMCF and performance evidence programs through registries, observational studies, and ongoing real-world follow-up.
Safety Reporting & Benefit-Risk Evaluation
- Support PSUR, SSCP/SSP, trend analysis, and benefit-risk reassessment through structured evidence updates.
Vigilance & Field Safety Response
- Manage serious incident assessment, regulatory reporting, field safety actions, and communication workflows across target markets.
Real-World Evidence & Data Analytics
- Convert complaints, feedback, literature, and post-market data into actionable evidence for compliance and decision-making.
Lifecycle Documentation & Regulatory Support
- Maintain PMS outputs, technical documentation updates, and post-market evidence packages aligned to ongoing regulatory expectations.
Post-Market Surveillance Lifecycle
A structured lifecycle for monitoring safety, performance, and benefit-risk after launch, while supporting regulatory compliance and continuous product improvement.
Foundational Set-Up
Establish the PMS framework, classify risk, define roles, and align the plan to regulatory expectations.
Data Collection
Capture post-market data from complaints, adverse events, recalls, studies, literature, registries, and real-world evidence.
Risk Evaluation
Detect signals, assess trends, and evaluate ongoing safety, performance, and benefit-risk.
CAPA & Updates
Investigate root causes and implement design, labeling, IFU, or software updates where needed.
Regulatory Reporting
Prepare PSURs, PMS reports, trend reports, vigilance submissions, and required communications.
Continuous Improvement
Use PMS findings to strengthen product, quality, clinical, and lifecycle decisions.
Technology and Standards for Post-Market Evidence
Our PMS programs are supported by IQA solutions, open technologies, analytical platforms, and standards-aligned regulatory practices for structured post-market evidence generation.
We combine post-market expertise, structured evidence workflows, and technology-enabled execution to help manufacturers generate defensible post-market evidence that supports safety, compliance, and lifecycle decisions.
Integrated Post-Market Expertise
We bring together PMS, PMCF, vigilance, safety reporting, evidence analytics, and regulatory support in one connected workflow.
Defensible Evidence Strategy
Our approach turns complaints, feedback, literature, registry data, and real-world performance into structured evidence that supports benefit-risk evaluation and ongoing compliance.
Technology-Enabled Delivery
Our post-market programs are strengthened by IQA solutions, analytical platforms, and regulatory intelligence that support signal detection, reporting readiness, and documentation control.
Regulatory-Ready Outputs
We support PMS reports, PSURs, PMCF outputs, vigilance submissions, and lifecycle documentation updates aligned to global expectations.
Lifecycle Continuity
We help manufacturers maintain post-market evidence across evolving risks, product changes, and regulatory requirements.
Built for Market Confidence
By identifying meaningful signals early and supporting proportionate action, we help protect patient safety, brand trust, and long-term market access.
Is Your Post-Market Evidence Defensive Enough?
From high-integrity data capture to high-authority PMCF studies powered by Evidexia - we keep your device compliant and commercially viable.