Content by Wade Schroeder
Software Bill of Materials for Medical DevicesThe FDA is looking to make them mandatory
Tue, 04/05/2022 - 12:02
On May 12, 2021, President Biden signed the Executive Order on Improving the Nation’s Cybersecurity. Among other items in the order was a requirement that every vendor that supplies the federal government with software must provide a software bill…
Risk Management for Medical DevicesGleaning best practices from regulatory standards
Thu, 09/02/2021 - 12:02
As more medical devices using network-connection technology are developed, cybersecurity will continue to grow in importance and focus among regulators and manufacturers. Many connected devices store or transmit patient data for which there is an…
How to Build Medical-Device Usability Testing and Validation Into Your Quality SystemA proactive approach to product development
Thu, 05/27/2021 - 12:03
Medical-device usability testing and validation are critical tasks leading up to a medical device’s debut on the market. “Usability” looks at how the user interacts with your device and forms a key component of overall risk management and safety.…