US FDA Traditional 510(K) Submission – A Step by Step Process
In the United States, medical devices are regulated under the Fed...
In Vitro Diagnostic Regulation (IVDR) – General Aspects, Key features and Limitations
Introduction to IVDR:
The In Vitro Diagnostic Regulation (IVDR) r...
Technical Documentation Best Practices for EU MDR
Manufacturers shall ensure the conformity of medical devices bein...
High Level Approach for PMCF Activities
The Medical Devices field is a constantly moving area. Several de...
Post-Market Clinical Follow-up Studies for Medical Devices
PMCF studies are not intended to replace the premarket data neces...
ISO 14971 Risk Management for Medical Devices
This standard specifies terminology, principles and a process for...