Standards for Medical Device Software: Friend, not Foe 2017

Topics

• Quality sounds like a buzzword, but it underlies everything else in our business
• Standards can be bewildering - get over it
• Risk Management is about how to MANAGE risks, not how to find and remove them
• Development lifecycle gives a framework
• Usability requires us to understand who were working to help
• Electrical equipment safety inevitably involves software
• Good engineering is our goal- compliance follows
• Planned changes will adapt these standards to new challenges

Who should Attend

• Project Managers (Especially for Cross-Functional Teams)
• Software Developers
• Requirements Analysts
• Business Analysts
• Product Managers
• Functional Managers - Software, Test, Hardware
• Other Development Specialists (Mechanical, Engineering, Other)