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Clinical Evaluation Report Consulting & Writing

Assess | Analyze | Execute

Clinical Evaluation Report Consulting & Writing

Clinical Evaluation Report Consulting & Writing

Assess | Analyze | Execute

Enhancing Clinical Efficacy and Safety

Enhancing Clinical Efficacy and Safety

The introduction of EU MDR/IVDR has led to rigorous post-market oversight and re-classification of devices. Comprehensive clinical and performance evaluation processes across medical device classes are thus crucial to ensure conformance to performance and safety norms.

This requires preparation of clinical and performance evaluation packages - literature reviews, data gathering, analysis and interpretation, risk-benefit assessment and re-assessment of claims. Many manufacturers lack clarity of the best practices for creating such Clinical and Performance Evaluation Reports (CER/PER). 

Tata Elxsi's diverse team of medical writers, clinical evaluation consultants, system engineers, and physicians/surgeons (MD) have vast experience in MEDDEV 2.7.1/Rev 4, EU MDR 2017/745, and IVDR 2017/746. We can be your perfect partner as you embark on this journey, providing the expertise needed to navigate regulatory requirements and innovate seamlessly.

Enhancing Clinical Efficacy and Safety
Here’s How We Can Help You

Here’s How We Can Help You

Here’s How We Can Help You

Compliance roadmap creation with strict adherence to regulatory requirements

  • Ready-to-use customisable compliance checklists and templates
  • Global regulatory intelligence platform, TEDREG, available for alerts to adapt to everchanging industry legislations and standards

Greater clinical evidence for medical and IVD devices to boost market acceptance

  • Streamlined data optimisation
  • Quicker response to changes in major geo-regulatory requirements preventing high-volume rework

Faster time-to-market 

  • Proactive engagement with Notified Bodies to minimise operational risks 
  • Efficient maintenance and  retrieval of records for sustained compliance

Service Framework

Clinical Evaluation Report Consulting & Writing

Why Tata Elxsi?

Expert Compliance and Regulatory Team with over a decade experience

  • Assistance for scientific communication
  • ICH-GCP certified clinical research experts to ensure timely delivery of Clinical Data Management (CDM)

Tata Elxsi's TEDREG: Global Regulatory Intelligence Platform

  • Rule-based automated daily update alerts and notifications to stay informed about the latest regulatory changes
  • Dashboards, bookmarks, and workflow management to enhance operational efficiency
  • Tracking specific events with search strings to retreive precise regulatory information

Ensure uninterrupted sale of devices 

  • Largest global offshore team of biomedical experts for rapid training and guidance to accelerate product development
  • Timely management of updated documents for submission to notified bodies to streamline the regulatory approval process

In Focus

Beyond EU MDR: Unleashing Opportunities to Innovate and Ensure Patient Safety

May 30, 2023

News - Medtech Intelligence

Beyond EU MDR: Unleashing Opportunities to Innovate and Ensure Patient Safety

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

Unfolding the EU MDR through the Lens of a Remediation Partner

Ensuring Uninterrupted Sales Of Legacy IVD Devices in the EU Market
Case Study

Ensuring Uninterrupted Sales Of Legacy IVD Devices in the EU Market

EU IVDR Compliance: Challenges Faced by the Manufacturers and the Role of a Remediation Partner
Technical Whitepaper

EU IVDR Compliance: Challenges Faced by the Manufacturers and the Role of a Remediation Partner

5 Ways to Transform Post Market Surveillance using Artificial Intelligence
Blog

5 Ways to Transform Post Market Surveillance using Artificial Intelligence

Impact of EU IVDR on Key Compliance Areas
Blog

Impact of EU IVDR on Key Compliance Areas

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