The Benefits of Using eIFU for Medical Device Manufacturers
In the rapidly evolving landscape of healthcare and medical device...
Medical Devices: Integrating RWE into CER for Post-market Devices
Introduction to Clinical Evaluation Reports (CERs)What is a Clinic...
eIFU Compliance: EU and FDA Guidelines
As the medical device industry continues to digitize, electronic I...
Medical Devices – USA, Europe and Asia Regulatory Updates Roundup – Jan 2025
USA
Guidance on Premarket Approval Application and Humanitarian De...
New/Key MDCG guidances in 2024
The European Commission continues to refine and expand regulatory ...
How Unique Device Identification (UDI) Transforms Global Medical Device Compliance
Compliance is very critical to the use of safe and effective medic...