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...
PMS Proactive & Reactive Data Sources for Devices
PMS processes are generating data, either continually or intermitt...
Singapore HSA Regulatory Guidelines for Software Medical Devices – A Life Cycle Approach
In March 2024, The document “Regulatory Guidance for Software Medi...
Differences between US FDA and EU MDR Usability Studies requirements
Regulatory frameworks for usability testing
IEC 62366-1:2015 is an...
Post-Market Surveillance Requirements for Medical Devices
Post-Market Surveillance requirements for Medical devices as per E...
