FDA Human Factors Engineering and Usability Guidelines
The FDA describes its requirements for human factors engineering ...
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...
PMS Proactive & Reactive Data Sources for Devices
PMS processes are generating data, either continually or intermit...
Singapore HSA Regulatory Guidelines for Software Medical Devices – A Life Cycle Approach
In March 2024, The document “Regulatory Guidance for Software Med...
Differences between US FDA and EU MDR Usability Studies requirements
Regulatory frameworks for usability testing
IEC 62366-1:2015 is a...