Clinical Evaluation Report Consulting & Writing

Assess | Analyze | Execute

Clinical and Performance Evaluation Report Consulting & Writing

Clinical Evaluation Report Consulting & Writing

Assess | Analyze | Execute

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Trending

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. 

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Opportunities & Challenges

Opportunities & Challenges

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: 

  • CER creation for newly classified and up-classified devices  

  • Clinical data availability & readiness  

  • Rigorous interpretation from high volume data  

  • Standardizing Post-Market Clinical Follow-up (PMCF) & Periodic Safety Update Report (PSUR) formats  

  • Clinical testing of products earlier exempted  

  • Keeping track of annual safety updates and maintaining dynamic data records 

  • Establishing state of the art (SOTA) with an extensive amount of supporting clinical data and applicable standards 

Service Framework

Clinical and Performance Evaluation Report Consulting & Writing
Service offerings
  • Gap analysis w.r.t EU MDR and MEDDEV 2.7/1 Rev 4 

  • Preparation of clinical evaluation plan | PMCF plan | Literature review plan 

  • Creation/ update of clinical evaluation packages | PMCF report | Literature review report | SSCP (Summary of Safety and Clinical Performance) 

  • Data gathering, analysis & interpretation: Literature search & appraisal | Claims list | Sales & complaints data | Risk analysis | Clinical investigation | Post-market surveillance | Corrective & Preventive Actions (CAPA) 

  • MAUDE data analysis 

  • Establishing State-of-the-Art (SOTA) 

  • Risk-benefit assessment 

  • Re-assessment of claims 

Differentiators

  • MEDDEV 2.7.1/Rev 3 & MEDDEV 2.7.1/Rev 4 experience

  • A diverse team of medical writers, clinical evaluation consultants, system engineers, and physicians/surgeons (MD) with extensive industry experience  

  • Comprehensive in-house training modules to ensure fast ramp-up

  • 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)

  • Data security in compliance with ISO 27001:2013

Benefits to the Customer

  • Active post-market oversight to make devices more robust, and enhance consumer trust in the brand  

  • High-quality CERs to avoid the episodes of rejection and subsequent product discontinuation, and for quick notified body approvals  

  • Thorough, objective, and reproducible search strategy to get the most from literature searches in the scoping stage  

  • The faster turnaround time to update CERs 

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