Residual Risk Analysis and User Interaction Problems: Risk Management Under EU MDR
Under the EU MDR, Risk is defined as the combination of the probab...
FDA Human Factors Engineering and Usability Guidelines
The FDA describes its requirements for human factors engineering i...
Adverse Event Reporting in UK – SaMD
Any event which meets these three reporting criteria is considered...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, Mar 2023
USA (FDA) | EUROPE | SWITZERLAND (SWISS MEDIC) | FINLAND (FIMEA) |...
Proactive strategies for Devices to minimize disruption
It is know that Medical devices have long as well as highly regula...
