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...
A Comprehensive Approach to Introducing Medical Devices into the Indian Market: Insights from Operon Strategist The Indian healthcare industry has...
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 Guide to Utilizing the FDA’s Best Practices for Choosing a Predicate Device When developing a new medical device, it...
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...
A Guide to Understanding EU Regulations for Combination Products in the Medical Device Market by Operon Strategist Introduction: Combination products,...
New Regulations Allow for More Class II & III Medical Devices in Clinical Trials In recent years, there has been...
The medical device industry is a rapidly growing sector of the healthcare industry, and it is essential for companies to...
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...
