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.