Is your Medical Device Software 510(k) Ready? 2018 is a conference that covers topics such as:
- 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
Is your Medical Device Software 510(k) Ready? 2018 brings together:
- 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
