Quality Management System: What ISO Standards Say About QMS
A quality management system is a huge part of producing medical devices. Whether you [...]
In Vitro Diagnostic Regulation (IVDR) Device Risk Management Challenges
All medical devices have their merit since all of them are used in the [...]
Medical Device Regulations – Links You Should Be Aware Of
Medical device regulations are no joke. It's pretty important to get the regulations right, [...]
Literature Search: How Much Research is Enough?
The research process is often thought of as a linear, straightforward path. You begin [...]
The Top 5 Regulatory Requirements for the Medical Device Industry
Being in the regulatory industry is not as cut and dry as most people [...]
Vigilance Reporting Under the MDR: Insider’s Guide
Implementing the European Medical Devices Regulation (MDR; 2017/745) and the In Vitro Diagnostic Medical [...]
7 Qualities of a Fantastic Medical Writer
Medical writers make up much of the medical device regulatory industry. In fact, they [...]
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 [...]