Clinical Evaluation
We turn clinical and performance evidence into submission-ready evaluations that supportregulatory decisions across major global markets.
Building Clinical Evidence Across the Device Lifecycle
Clinical evaluation is a continuous evidence process that demonstrates a medical device’s safety,performance, and clinical benefit across its lifecycle.
Our approach brings together literature, clinical investigation data, post-market experience, andtransparent State of the Art rationale into a unified clinical evidence strategy. From CEP planning andCER development to PMCF execution, we help manufacturers maintain clinical evidence thatsupports GSPRs, EU MDR compliance, regulatory submissions, and sustained market approval.
Core Elements
Connect CEP, CER, and PMCF within one evidence strategy.
Support evaluations with robust methods and transparent justification.
Align evidence to GSPRs, EU MDR, and submission expectations.
Sustain clinical evidence through post-market follow-up and updates.
Capabilities That Strengthen Clinical Evaluation Across the Lifecycle
We support medical devices and IVDs with the scientific, clinical, and regulatory capabilities needed to build defensible evaluation evidence from planning through submission and ongoing compliance
Clinical Evaluation Strategy
- Define evidence pathway through CEP planning
- Intended purpose alignment
- Endpoint strategy definition
- Regulatory evidence planning
State of the Art & Literature Appraisal
- Conduct structured literature review, screening, appraisal, and SOTA analysis to support clinical and performance evaluation.
CER & PER Development
- Prepare clear, defensible Clinical Evaluation Reports and Performance Evaluation Reports aligned to applicable regulatory expectations.
Clinical & Performance Evidence Analysis
- Integrate literature and study data
- Analytical performance evaluation
- clinical performance evidence into a coherent evaluation framework
Regulatory Writing & Documentation
- Develop submission-ready documentation
- Support MDR / IVDR requirements
- Global regulatory alignment
Lifecycle Evaluation Maintenance
- Support updates to clinical evaluation documentation as new evidence, product changes, and regulatory expectations evolve.
A structured lifecycle for planning, developing, and maintaining clinical evaluation evidencethat supports safety, performance, compliance, and sustained market approval.
Strategy & Scope
Define intended purpose, claims, and evaluation strategy.
SOTA & Literature
Establish the state-of-the-art framework and evidence search plan.
Evidence Appraisal
Review literature, clinical, performance, and post-market data.
Gap Assessment
Identify whether available evidence sufficiently supports the device.
CER / PER Development
Build a clear, defensible evaluation aligned to regulatory expectations.
Lifecycle Updates
Maintain evaluation as new evidence and regulatory needs evolve.
Technology-Enabled Clinical Evaluation, Built on Global Standards
We support clinical evaluation with structured evidence workflows, literature and SOTAreview, document traceability, and standards-aligned practices for medical devices and IVDs.
We combine scientific rigor, regulatory alignment, and technology-enabled workflows tohelp manufacturers build defensible clinical evaluation evidence for submissions, compliance, andsustained market approval
Integrated Expertise
Literature, SOTA, evidence appraisal, and regulatory writing in one workflow
Defensible Strategy
Clear evidence planning linked to intended purpose, claims, and risks. Regulatory-ready documentation including CEP, CER, and PER with traceable submission-ready outputs
Lifecycle Continuity
Ongoing updates as evidence, products, and regulations evolve
Technology-Enabled Delivery
Digital workflows and RegIntelli-powered intelligence strengthen execution
Ready to Secure Your Clinical Evidence from Pilot to Approval?
Experience the seamless communication of TrialLattice and the biometric precision of the IQA Advantage.