Software as a Medical Device
Healthcare is undergoing a paradigm shift as cutting-edge technology makes its way into medical [...]
Quality Management System: What ISO Standards Say About QMS
A quality management system is a huge part of producing medical devices. Whether you [...]
The Top 5 Regulatory Requirements for the Medical Device Industry
Being in the regulatory industry is not as cut and dry as most people [...]
Navigating Global Medical Device Regulations
Understanding the Landscape of Global Medical Device Regulations The global landscape of medical device regulations [...]
7 Qualities of a Fantastic Medical Writer
Medical writers make up much of the medical device regulatory industry. In fact, they [...]
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 [...]
Publishing Clinical Trials Results in Journals
Clinical trials are a crucial piece of launching a medical device. Publishing the data [...]
Analyzing the Differences between CERs for MDR versus MDD
Implementing the MDR or Medical Device Regulation will bring significant changes to the process [...]
Classifying Software as Medical Device in EU MDR
Introduction to Software as a Medical Device in MDR The MDCG's Guidance document defines the [...]
Are You Over-Committing on Your EU MDR Post-Market Surveillance Plan?
All MedTech companies face increased post-market surveillance (PMS) requirements under the EU MDR and [...]