Software Development for Medical Devices: Overcoming the Challenges of Compliance, Quality and Cost
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Software is fast becoming the differentiator for manufacturers of medical devices. The rewards available from software innovation are balanced by the risks and challenges of FDA regulation, stringent quality requirements, market pressures, and significant complexity. This paper reviews some of the key challenges facing the medical device industry, and examines the role that an application lifecycle management (ALM) platform can play in meeting the primary challenges regarding FDA compliance, device and software quality, and cycle time and cost.