As pharmaceutical and biotech companies strive to meet evolving FDA standards, they encounter rigorous inspections aimed at ensuring quality, safety,...
Navigating the New FDA Cybersecurity Guidance for Medical Devices
As healthcare technology continues to evolve, medical devices are increasingly connected to networks, patients, and other devices, making them...
Top 7 FDA Inspection Findings in Medical Device Companies in 2024
In 2024, the FDA remains focused on ensuring that medical device companies adhere to stringent regulatory requirements to guarantee patient safety...
Top Medical Device Markets with High Growth Potential
The medical device landscape is rapidly evolving, with advances in technology and shifts in patient needs creating new opportunities for innovation....
New Initiatives in Life Sciences: What a Harris vs. Trump Election Could Mean for FDA Regulations
The U.S. presidential election could signal significant changes in the direction of FDA regulations within the life sciences industry. This article...
Understanding Investigational Device Exemptions (IDEs) for Medical Devices
Investigational devices are medical devices that are still undergoing evaluation and have not yet received regulatory approval or clearance from...
FDA Regulatory Impacts for Medical Devices: Trump vs. Harris Presidency
As the U.S. election approaches, industries closely regulated by federal agencies, like the medical device sector, are keenly watching for potential...