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 

Discover More

Updating the CERs as per EU MDR guidelines (Class II and III)
Case Study

Updating the CERs as per EU MDR guidelines (Class II and III)

Reduction in turnaround time by 20 – 25% for CER creation
Case Study

Reduction in turnaround time by 20 – 25% for CER creation

Unfolding the EU MDR through the Lens of a Remediation Partner
Technical Whitepaper

Unfolding the EU MDR through the Lens of a Remediation Partner

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