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, [...]
Quality Management System: What ISO Standards Say About QMS
A quality management system is a huge part of producing medical devices. Whether you [...]
Software as a Medical Device (SaMD): EU MDR and FDA Regulatory Overview
Healthcare is undergoing a paradigm shift as cutting-edge technology makes its way into medical [...]
Unexpected Documents You Might Need for Your Clinical Evaluation Report
Medical device regulation is important. Not just because we work with them. But because [...]
Your MDR Readiness Checklist
The new EU MDR Regulations Everything you needed to know in 2020 The final [...]
MEDDEV 2.7.1 Revision 4: Guidelines for Clinical Evaluation
In accordance with the European directive for medical devices 93/42/EEC, ‘manufacturers must provide proof [...]
Publishing Clinical Trials Results in Journals
Clinical trials are a crucial piece of launching a medical device. Publishing the data [...]
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 [...]
Analyzing the Differences between CERs for MDR versus MDD
Implementing the MDR or Medical Device Regulation will bring significant changes to the process [...]