FDA’s RWE Guidance Updates: What Manufacturers Need to Know
Introduction In early 2026, the U.S. Food and Drug Administration (FDA) signaled a meaningful shift in how real-world evidence (RWE) can be…
15 Apr 2026
Living Systematic Reviews for Medical Devices: Enabling Continuous Clinical Evaluation Under EU MDR
Introduction: The Continuous Problem Under the European Medical Device Regulation (EU MDR 2017/745), clinical evaluation is defined as a continuous process (Article…
29 Mar 2026
Navigating Appraisal and Weighting Under MDR 2017/745
A Comprehensive Guide for Medical Device Evidence Assessment Introduction Appraisal and weighting of clinical data are among the most critical steps in…
17 Mar 2026
CER Writing Strategy Guide: How to Write a Compliant EU MDR CER
How to Write a Compliant Clinical Evaluation Report Under EU MDR 2017/745 Introduction The Clinical Evaluation Report (CER) is the central regulatory…
11 Mar 2026
In-House vs Outsourced CER Writing Under EU MDR: Strategic Considerations for Medical Device Manufacturers
Introduction Under the European Union Medical Device Regulation (EU MDR), the Clinical Evaluation Report (CER) has become one of the most scrutinised…
03 Mar 2026
FDA Literature Review – Class III PMS and Indication Expansion
Introduction Why FDA increasingly expects robust literature evidence for Class III devices For Class III medical devices, the U.S. Food and Drug…
16 Feb 2026
Complete Guide to Copyright and Usage for Medical & Literature Review Writers
1. Introduction: Why Copyright Matters in Scientific Writing Copyright is a fundamental yet often misunderstood aspect of scientific writing. Every published research…
07 Feb 2026
Turning Complex Medical Data Into Engaging Reader-Friendly Stories
Turning Complex Medical Data into Engaging, Reader-Friendly Stories How to Transform Evidence into Clear, Actionable and Trustworthy Medical Narratives By Dr. Alyssa…
12 Dec 2025