Learn how one company cut FDA validation costs 50%

Medical device software—and software that's used to design, develop, or manufacture medical devices—must comply with the FDA's Quality System regulation.

To demonstrate compliance, the FDA software validation guidance recommends a comprehensive software development lifecycle that integrates risk management strategies with principles for software validation. 

Download this 12-page eKit to learn...

• The key to making compliance a continuous and sustainable process
• How a policy-driven process enables compliance in the least burdensome manner
• What the FDA recommends in terms of peer code reviews, static analysis, unit testing, regression testing, and requirements traceability
• Strategies for orchestrating all required planning, validation, and approval/sign-off tasks—both automated and manual
• How Bovie Medical cut validation and verification costs in half... while increasing quality and productivity