Systematic Literature Review Course
Welcome to the Systematic Literature Review Course!
Lesson 2 – Systematic Literature Review Course: Selecting Your S&P Criteria and Clinical Claims
Missed last week? Read our Past Lesson: Search Protocol Key Sections. Be sure to check it out if you [...]
Lesson 3 – Systematic Literature Review Course: Literature Search Terms and PICO
Missed last week? Read our Past Lesson: Selecting Your S&P Criteria and Clinical Claims. Be sure to check it [...]
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 or conference proceedings that are relevant [...]
Literature Reviews for EU MDR
Want to know what the most commonly criticized document in an MDR submission is? Your clinical literature review. Reviewing [...]
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 the European Parliament and Council, came [...]
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 format of a Clinical Evaluation [...]
Classifying In Vitro Diagnostic Medical Devices Under The MDR
May 26, 2022, marks the start of the 5-year staggered implementation of the In Vitro Diagnostic Medical Devices Regulation (IVDR, [...]
Fundamentals of a Literature Review: A Beginner’s Guide
The medical device industry is fueled by innovation. Research and development are the blood that keeps it going. Each [...]
EU MDR: Combination Products – An Overview
We all know and love (ahem) the EU MDR (2017/745). And although it is defined as the EU Medical [...]