• Regulatory considerations in early development
• Access publicly available databases early on
• “Can you sell me this pen?” Three easy steps to develop an initial regulatory, quality, and clinical strategy and then sell it to senior management.
• Establishing and initiating the project
  • Mapping out timelines, responsibilities, and management
  • Records management and documentation
  • Identify ways to incorporate quality planning into a project
• Common myths, best practices, and tools – Lessons learned

• Which regulations and standards apply to your device?
• Establishing and monitoring standards in medical deviceproject management
• Incorporating regulatory requirements and considerationsthroughout the medical device lifecycle (clinical evaluation,safety, and risk management)
• Additional regulatory considerations for project management(quality system requirements, design control, vendor control)
• Common myths, best practices, and tools – Lessons learned

• Systematic literature reviews, appraising and analyzing literature
• Clinical investigations, registries, hospital databases, and surveys
• Post-market activities, complaint handling, vigilance, and CAPA
• Access publicly available databases
• Common myths, best practices, and tools – Lessons learned

• Practicalities of risk management
• Benefit-risk analysis – the unsolvable equation
• Common myths, best practices, and tools – Lessons learned

• Metrics used for project management
• Metrics used for notified body performance
• Adapting to change – significant changes will occur
• Understanding full lifecycle expectations
• Discuss how to optimize team performance, communication, and interaction
• Common myths, best practices, and tools – Lessons learned

Delegates will get the opportunity to finish the course by asking any remaining questions and queries regarding the course content.