Systematic Literature Review Course
Welcome to the Systematic Literature Review Course!
Five Practical Tips for Writing a Compliant Clinical Evaluation Report (CER)
Even for experienced medical writers and regulatory staff, writing a compliant clinical evaluation report (CER) for medical devices can [...]
EU In Vitro Diagnostic Regulation (IVDR): Frequently Asked Questions
The regulatory landscape in Europe is changing. In 2021, the new medical device regulation was implemented; in 2022, it [...]
Analyzing the Differences between CERs for MDR versus MDD
Implementing the MDR or Medical Device Regulation will bring significant changes to the process of Clinical Evaluation and subsequent [...]
IVDR: State-of-the-Art for In Vitro Diagnostic Medical Devices
With the updates to the European Medical Device and In Vitro Diagnostic Device Regulations (MDR 2017/745 and IVDR 2017/746, [...]
Publishing Clinical Trials Results in Journals
Clinical trials are a crucial piece of launching a medical device. Publishing the data you have gathered regarding the [...]
Annual Safety Report: Clinical Trial Reporting Requirements in EU Countries – CiteMed
Introduction Clinical trials are a fundamental component of medical product development, providing a controlled environment to evaluate the safety [...]
MEDDEV 2.7.1 Revision 4: Guidelines for Clinical Evaluation
In accordance with the European directive for medical devices 93/42/EEC, ‘manufacturers must provide proof of and document the performance [...]
Your MDR Readiness Checklist
The new EU MDR Regulations Everything you needed to know in 2020 The final period for compliance with EU [...]
Building Your PMS Templates
This document intends to cover a comprehensive framework for each of your products. Use it as a guide to [...]