Systematic Literature Review Course
Welcome to the Systematic Literature Review Course!
Top 10 Literature Search Tools Every Medical Writer Should Know
Medical writing is hard. It's tricky, technical, and sometimes exceptionally tedious. Suppose you chose literature reviews as your niche [...]
Navigating Global Medical Device Regulations
Understanding the Landscape of Global Medical Device Regulations The global landscape of medical device regulations is as diverse as it [...]
Systematic Literature Reviews
The MDR forces manufacturers to set up processes for continuous literature reviews and reevaluation of the available clinical data. [...]
Clinical Evaluation Report (CER) vs. Periodic Safety Update Report (PSUR)
Every medical device on the European market must be continuously monitored to confirm its safety and efficiency for patients [...]
EU IVDR Regulation: A Brief
IVDR is a separate regulation compared to the European medical devices regulation. However, it is closely associated with the [...]
Post Market Clinical Follow Up Medical Devices: Requirements and Key Methods Under EU MDR
Under the European Medical Device Regulation (EU MDR 2017/745), manufacturers are required to conduct post-market clinical follow-up (PMCF) as [...]
CER for Software as a Medical Device in the EU
The medical device industry has been changing bit by bit every day, and one of the significant changes is [...]
In Vitro Diagnostic Devices Regulation (IVDR) and How It Relates to CE markings
CE marking indicates compliance with an EU directive so that you can market your products in the EU. It's [...]
What Is a Legacy Device, and What Do Manufacturers Need to Know About It?
The MDR is a sweeping reform of medical device regulation in Europe that aims to strengthen safety and quality. [...]