US FDA Traditional 510(K) Submission – A Step by Step Process
In the United States, medical devices are regulated under the Fede...
US FDA Medical Device Labeling Requirements
What Is Medical Device Labeling?
According to the FDA, medical dev...
In Vitro Diagnostic Regulation (IVDR) – General Aspects, Key features and Limitations
Introduction to IVDR:
The In Vitro Diagnostic Regulation (IVDR) re...
Technical Documentation Best Practices for EU MDR
Manufacturers shall ensure the conformity of medical devices being...
High Level Approach for PMCF Activities
The Medical Devices field is a constantly moving area. Several dev...
Literature Search: A Medical Writer perspective
A thorough and organized search of the previously published data i...
