US FDA Medical Device Labeling Requirements
What Is Medical Device Labeling?
According to the FDA, medical dev...
FDA Human Factors Engineering and Usability Guidelines
The FDA describes its requirements for human factors engineering i...
Technical Documentation Best Practices for EU MDR
Manufacturers shall ensure the conformity of medical devices being...
General Safety and Performance Requirements (GSPR)
What is GSPR?        The GSPR is known as General Safety and Perf...
Singapore HSA Regulatory Guidelines for Software Medical Devices – A Life Cycle Approach
In March 2024, The document “Regulatory Guidance for Software Medi...
ISO 14971 Risk Management for Medical Devices
This standard specifies terminology, principles and a process for ...
