Clinical and Performance

April 3, 2026
Medical Devices,
Clinical and Performance
IVDR PMS, PMPF, and PSUR: Building a Robust, Traceable Evidence System for IVD Compliance
March 20, 2026
Medical Devices,
Clinical and Performance
Sufficient IVDR Clinical Evidence: Navigating MDCG 2022-2 and Notified Body Expectations
March 20, 2026
Medical Devices,
Clinical and Performance
Designing a Clinical Performance Study IVD: Bias Control, Endpoints, and QUADAS-2 Methodology Introduction
March 17, 2026
Medical Devices,
Clinical and Performance
State of the Art (SOTA) in CERs – EU MDR Clinical Benchmarking
March 17, 2026
Medical Devices,
Clinical and Performance
Clinical Evaluation Reports Under EU MDR: Notified Body Expectations
February 18, 2026
Medical Devices,
Clinical and Performance
Clinical Evaluation for SaMD and AI-Based Medical Devices: Applying MDR Principles to Algorithms
February 18, 2026
Medical Devices,
Clinical and Performance
Comprehensive Guide to IVDR Performance Evaluation & Performance Evidence Requirements
February 18, 2026
Medical Devices,
Clinical and Performance
Article 61 Clinical Evaluation: Defending Sufficient Clinical Evidence for Legacy and New Devices
February 18, 2026
Medical Devices,
Clinical and Performance
MDR PSUR, PMS, and PMCF: Designing a Traceable and Cohesive Post-Market Evidence System
February 2, 2026
Medical Devices,
Clinical and Performance
Comprehensive Guide to MDR Clinical Evaluation & Clinical Evidence Requirements
November 13, 2025
Medical Devices,
Clinical and Performance
The Power of Systematic Literature Reviews: Strengthening Clinical Evaluation Reports for Medical Devices