In addition to being a prevalent cause of medical device recalls, software-related recalls are also rising steadily, accounting for a 111% cumulative increase since 2010. Unlike other root causes of device issues, software-related recalls are unique in the ...
Understanding IEC 62304: Best Practices & Avoiding Mistakes - This video will enable you to quickly understand IEC 62304, the international standard for medical device software;
- Contrast IEC 62304 with CMMI and other safety-critical standards
- Understand the top five mistakes in applying IEC 62304 and how to avoid them
- Understand the top five Best Practices in successful IEC 62304 deployment
At the Heart of IEC 62304 Medical Devices - Terumo sought to ensure improvements in software quality and reduce risk for their life-saving DuraHeart™ Left Ventricular Assist System LVAS device, an implantable device that combines patented magnetic levitation and centrifugal pump technologies to assist the left side of the heart in pumping blood. The DuraHeart LVAS improves circulation throughout the body; decreasing the risk of cell damage and its associated