Improve Safety in Medical Device Software
	What can go wrong with medical device software?	Possible Solutions
Supplier	Many systems development catastrophes begin with the selection of a low bidder to do a project. The low bidder could be a small and inexperienced supplier.	· Cost should NOT be the only criteria for designation. Investigate the bidders’ software development ability, especially when the project is big. Several organizations are creating new methods for evaluating the capability of bidders on software development project.
Coding	Bugs are far more dangerous and prevalent. The most insidious software errors are often caused by the poorly handled sharing of date and other resources by competing processes.	Be aware of the data that can be shared. Surround the critical sections of the code with interrupt disabling or task locks to prevent interruption. Encapsulation of object orientation enforces the hiding of private data by preventing uncontrolled access. Any global data and systems with multivariable state descriptions are checked for possible errors.
Testing	The testing is not sufficient and adequate. Doesn’t have an extensive test plan. Even if the product is delivered to the test group late, the product shipping date is seldom adjusted accordingly. And time-to-market pressures force testers to cut corners. Discount low-probability, high impact events. The use of “black-box” testing in which testers have no knowledge of what is inside the box—the internal working of the device	Develop an extensive test plan, which must be accepted by upper management and must be adaptable. Cycle testing is a technique that can be used in medical device software testing. Don’t let the pressure to deliver on time overshadow long-term risks and costs. Use “white-box” testing method instead of “black-box” testing method. uses computer technology to test computer software.
Increasing Safety with Risk Management	It may not be possible to exercise the software with sufficient rigor to observe the defect under the variety of conditions in which it will be used by customers. It’s impossible to have a risk-free medical device software	Companies can manage and reduce risk more effectively by including risk thinking as early as possible in device or process development and revisiting those issues systematically throughout the development process. Hazard analysis consists of listing the major components and operating requirement of the device and evaluating their potential hazards.