EU MDR: Combination Products – An Overview
We all know and love (ahem) the EU MDR (2017/745). And although it is [...]
Fundamentals of a Literature Review: A Beginner’s Guide
The medical device industry is fueled by innovation. Research and development are the blood [...]
Classifying In Vitro Diagnostic Medical Devices Under The MDR
May 26, 2022, marks the start of the 5-year staggered implementation of the In [...]
Clinical Evaluation Assessment Report Rubric: What Does It Mean For Your MDR Submissions?
MDCG’s Guidance document, released in July 2020, introduces and details the key requirements and [...]
Updates To The EU Blue Guide: Impacts on Market Surveillance of Medical Devices
In July 2021, Regulation (EU) 2019/1020 on market surveillance and product compliance, issued by [...]
How Literature Review Automation Improves Performance Evaluation Reports (PER) Program Management for the IVDR
A literature review is a formal collection of scientific studies published in peer-reviewed journals [...]
Literature Reviews for EU MDR
Want to know what the most commonly criticized document in an MDR submission is? [...]
Effectively Handling Corrective and Preventive Actions (CAPA) Process with EU MDR
The EU MDR emphasizes field safety corrective actions to correct non-conformances of the distributed [...]
Breaking Down EU MDR Implementation for Class 1 Medical Devices
Breaking Down EU MDR Implementation for Class 1 Medical Devices Following the one-year delay [...]
Post Market Surveillance EU MDR – CiteMed
Post-market surveillance (PMS) under the EU MDR (2017/745) is a systematic and proactive process [...]