US FDA’s UDI Requirements
FDA UDI regulations were released in the final UDI Rule on Septemb...
In Vitro Diagnostic Regulation (IVDR) – General Aspects, Key features and Limitations
Introduction to IVDR:
The In Vitro Diagnostic Regulation (IVDR) re...
Medical Devices Clinical Monitoring Best Practices
Effective Medical Device clinical trial monitoring is essential fo...
PMS Proactive & Reactive Data Sources for Devices
PMS processes are generating data, either continually or intermitt...
Post-Market Surveillance Requirements for Medical Devices
Post-Market Surveillance requirements for Medical devices as per E...
The Importance of Statistical Monitoring in ICH E6 (R2) Addendum
Statistical monitoring (SM) involves the review of ongoing prospec...
