An Overview of the CE Marking Process in the European Union
You want to sell your device in the European Union and start the CE marking [...]
Tips and Tricks for How to Conduct a Literature Review with Endnote
The literature review is a critical part of any clinical evaluation. It's where you collect [...]
EU MDR Clinical Evaluation Requirements – Understanding the CER
EU MDR Clinical Evaluation Requirement – Understanding the CER A critical component of the [...]
Clinical Trials Reporting Requirements in EU Countries
Clinical trials are important. The discovery of any new medical treatments is a standard [...]
Publishing Clinical Trials Results in Journals
Clinical trials are a crucial piece of launching a medical device. Publishing the data [...]
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 [...]
Analyzing the Differences between CERs for MDR versus MDD
Implementing the MDR or Medical Device Regulation will bring significant changes to the process of [...]
EU In Vitro Diagnostic Regulation (IVDR): Frequently Asked Questions
The regulatory landscape in Europe is changing. In 2021, the new medical device regulation [...]
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 [...]
7 Qualities of a Fantastic Medical Writer
Medical writers make up much of the medical device regulatory industry. In fact, they [...]
