Is your Medical Device Software 510(k) Ready? 2018

Topics

• What constitutes Compliance prior to the Submittal
• The key components of ensuring the Software part of your submittal is not rejected
• Software development life cycle (SDLC)
• Leading barriers in your organization for
• Key regulations, standards, and guidance documents
• Verification and validation, including regulatory definitions, regulatory intent, and common tasks
• Design control and software validation guidance
• Integrating risk management processes in your submittal
• Methods development and documentation requirements
• Testing level strategies (unit, integration, system, user)
• Documentation requirements for premarket submissions
• Test protocol content
• Design and quality planning, including traceability and reviews
• Processes, procedures, and outputs for typical phases (examples, roles, relationships)
• Lessons learned from case studies and warning letters

Who should Attend

• Medical Device Software Quality Assurance Engineers
• Medical Device Software Regulatory professionals
• Medical Device Software Company Senior Management
• Medical Device Software Quality Senior Management
• Medical Device Quality Senior Management
• Medical Device Quality Engineers
• Medical Device Software Engineers
• Medical Device Software Engineering Manager
• Medical Device Software Company CEOs
• Medical Device Software R+D Managers
• Medical Device Software VP Engineering