Medical Device Cybersecurity
Recommended Practices for Software-Contained Device Manufacturer Why Cybersecurity for Medical Devices? As more medical device software is released to the market, information exchange and integration between…
How to Prepare Human Factors Documentation for the FDA Premarket Submission
When medical devices are user-friendly there is a higher probability for users to continue using the device for clinical or personal purposes and highly recommend the…
Software as a Medical Device (SaMD) Audit Challenges
Software as a Medical Device (SaMD) is no longer an emerging vocabulary in 2022. With the rapid development of medical digitalization, medical devices are no longer…
Align Agile Practices with QMS Requirements
By Allen Chen, Senior Quality Engineer at Rook Quality Systems Taiwan Branch Agile is a practical framework and an iterative approach for product development and project…