The Benefits of Using eIFU for Medical Device Manufacturers
In the rapidly evolving landscape of healthcare and medical device...
Medical Device Adverse Event Reporting Regulations: EU vs. US FDA
Regulatory authorities in both Europe and the United States requir...
Effective Clinical Overviews: Regulatory Submissions
The Clinical Overview is a pivotal component of the Common Technic...
Medical Devices – USA, Europe and Asia Regulatory Updates Roundup – Jan 2025
USA
Guidance on Premarket Approval Application and Humanitarian De...
Regulatory Compliance Guide for SSCP Professionals
Summary of Safety and Clinical Performance (SSCP) is a new Regulat...
The Role of Clinical Monitoring in the Success of Medical Device Trials in the USA
Clinical monitoring is an indispensable component of the medical d...
