Abstract:

Since medical devices increasingly employ sophisticated software, who's failure to function correctly could result in death or serious injury, various government bodies are taking action to ensure that medical devices comply with rigorous standards. For medical device software developers, increased government scrutiny and new international standards create a compliance burden that challenges time-to-market goals and threatens to explode software development costs. With a brief overview of new standards such as IEC 62304, LDRA will show you how to manage your product development throughout the entire software development lifecycle which will help you to meet the new medical standards through better process management solution that cuts costs while improving software quality.