Responsibilities for Medical Devices Vigilance Reporting
Medical devices are regulated differently across the globe. Each c...
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...
eIFU for Medical Devices: Country Specific Regulations and Benefits
There are several benefits of using electronic Instructions for Us...
