CER for Software as a Medical Device in the EU
The medical device industry has been changing bit by bit every day, and one [...]
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 [...]
EU IVDR Regulation: A Brief
IVDR is a separate regulation compared to the European medical devices regulation. However, it [...]
Literature Search: How Much Research is Enough?
The research process is often thought of as a linear, straightforward path. You begin [...]
Navigating Global Medical Device Regulations
Understanding the Landscape of Global Medical Device Regulations The global landscape of medical device [...]
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 [...]
Vigilance Reporting Under the MDR: Insider’s Guide
Implementing the European Medical Devices Regulation (MDR; 2017/745) and the In Vitro Diagnostic Medical [...]
The Top 5 Regulatory Requirements for the Medical Device Industry
Being in the regulatory industry is not as cut and dry as most people [...]
Medical Device Regulations – Links You Should Be Aware Of
Medical device regulations are no joke. It's pretty important to get the regulations right, [...]
Post-Market Surveillance, Market Surveillance, and Vigilance – What is the Difference?
Most regulatory staff can define post-market surveillance relatively succinctly. Perhaps also vigilance. But when [...]