2-day In-person Seminar on Software Risk Analysis Tools for Medical Devices and Risk Mitigation at San Diego

The FDA recalls related to software performance are on the increase for at least five years at the time of this writing. Software failures were behind 24 percent of all the medical device recalls in 2011, according to data from the FDA. Similar to hardware, software also has hazards (any source of harm) and hazardous situations which transform a hazard into harm. They must identify hazards and identify what event can turn them into harm and write software specifications to prevent such combinations. The risk management tools such as FMEA (Failure Mode and Effects Analysis), FTA (Fault Tree Analysis) can help to mitigate software risks. These tools are covered in the Chapter 4. The mitigations from using the tools become the new requirements in the software specification.