Understanding the Distinctions between SaMD and SiMD in Medical Device Guidelines In the rapidly evolving field of healthcare technology, software...
A Guide to Selecting Medical Device Software for Development under QMS In today’s technologically advanced world, medical device software plays...
Insights from the 13th China International Medical Device Regulatory Forum (CIMDR) and a Look Ahead to the 14th CIMDR in...
Understanding Regulatory Budgeting for Drug-Device Combination Products: A Guide to EU MDR Compliance by Operon Strategist Introduction: The field of...
Essential Tips for Successful Medical Device Manufacturing: A Comprehensive Guide Medical device manufacturing is a complex and highly regulated industry...
A Comprehensive Overview of Device Class Requirements under EU MDR The European Union Medical Device Regulation (EU MDR) is a...
A Comprehensive Overview of the Timeline for Implementing MDR Extension The Medical Device Regulation (MDR) is a set of regulations...
Differences in Clinical Investigation Requirements: A Comparison of FDA and EU MDR Clinical investigations play a crucial role in the...
New Regulations Allow for More Class II & III Medical Devices in Clinical Trials In recent years, there has been...
Medical device regulation compliance is an important part of ensuring the safety of patients and the quality of medical products....
The European Union (EU) has recently implemented a new medical device regulation (MDR) to ensure the safety and effectiveness of...
The European Union (EU) Medical Device Regulation (MDR) has had a significant impact on medical device innovation since it was...
The European Union Medical Device Regulation (EU MDR) is a major piece of legislation that has been implemented to ensure...
The European Union (EU) Medical Device Regulation (MDR) has been in effect since May 2020 and has had a significant...
The European Union (EU) has recently implemented a new medical device regulation that is set to have a major impact...
