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Clinical and Performance Evaluation Report Consulting & Writing
Clinical Evaluation Report Consulting & Writing
Assess | Analyze | Execute
Clinical Evaluation Report Consulting & Writing
Assess | Analyze | Execute
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As per the latest EU regulatory requirements, manufacturers must create and maintain a Clinical Evaluation Report (CER) and a Performance Evaluation Report (PER) for their medical device and in vitro diagnostic device, respectively.
Amidst the organization-wide changes triggered by EU MDR and IVDR, manufacturers are required to present convincing interpretations to justify safety and clinical performance through clinical or performance evaluation reports (CER/ PER). Moreover, increased transparency in post-market performance and safety documentation is adding to the administrative burden, which may lead to significant business implications in the form of loss of revenue and increased time-to-market.
Opportunities & Challenges
EU MDR/IVDR has led to rigorous post-market oversight and re-classification of devices, calling for a comprehensive performance and clinical evaluation process across the medical device classes.
Challenges for the companies in complying with the new CER requirements:
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CER creation for newly classified and up-classified devices
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Clinical data availability & readiness
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Rigorous interpretation from high volume data
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Standardizing Post-Market Clinical Follow-up (PMCF) & Periodic Safety Update Report (PSUR) formats
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Clinical testing of products earlier exempted
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Keeping track of annual safety updates and maintaining dynamic data records
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Establishing state of the art (SOTA) with an extensive amount of supporting clinical data and applicable standards
Service Framework
Service offerings
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Gap analysis w.r.t EU MDR and MEDDEV 2.7/1 Rev 4
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Preparation of clinical evaluation plan | PMCF plan | Literature review plan
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Creation/ update of clinical evaluation packages | PMCF report | Literature review report | SSCP (Summary of Safety and Clinical Performance)
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Data gathering, analysis & interpretation: Literature search & appraisal | Claims list | Sales & complaints data | Risk analysis | Clinical investigation | Post-market surveillance | Corrective & Preventive Actions (CAPA)
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MAUDE data analysis
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Establishing State-of-the-Art (SOTA)
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Risk-benefit assessment
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Re-assessment of claims
Differentiators
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MEDDEV 2.7.1/Rev 3 & MEDDEV 2.7.1/Rev 4 experience
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A diverse team of medical writers, clinical evaluation consultants, system engineers, and physicians/surgeons (MD) with extensive industry experience
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Comprehensive in-house training modules to ensure fast ramp-up
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A repository of ready-to-use checklists (e.g., gap analysis and pre-submission review checklists) and templates (e.g., clinical evaluation plan, literature search plan and report, PMCF plan and report, and clinical evaluation report templates)
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Data security in compliance with ISO 27001:2013
Benefits to the Customer
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Active post-market oversight to make devices more robust, and enhance consumer trust in the brand
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High-quality CERs to avoid the episodes of rejection and subsequent product discontinuation, and for quick notified body approvals
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Thorough, objective, and reproducible search strategy to get the most from literature searches in the scoping stage
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The faster turnaround time to update CERs
Discover More
Technical Whitepaper
Unfolding the EU MDR through the Lens of a Remediation Partner
Blog
5 Ways to Transform Post Market Surveillance using Artificial Intelligence
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