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Benefits to you

Legal regulations

The course includes information on applicable laws and regulations, CE marking, risk management (ISO 14971), usability (EN 62366), software lifecycle processes (EN 62304), and other essential standards.

Course materials

Each attendee receives hand-out slides and templates to use in their project

Course certificate

At the end of the course, each attendee receives a course certificate confirming the knowledge they have gained about project management for medical device product development.

Course program

Day 1

  • Introduction
  • Project management
  • Project models
  • The regulatory framework
  • Standards
  • Documents and records
  • Product approval process
  • What is enough
  • Key elements of design control
  • The project process for the course

Day 2

  • Selecting tools and techniques
  • Develop project charter
  • Planning phase
  • Collect requirements
  • Define design and development inputs
  • Define scope
  • System design incl Usability
  • Risk management
  • Plan verification and validation
  • Create WBS

Day 3

  • Scheduling
  • Develop human resource plan
  • Project risk management
  • Estimate cost and Determine budget
  • Develop project management plan
  • Design review
  • Direct and manage project execution
  • Control schedule/Control costs
  • Control scope

Day 4

  • Report performance
  • Monitor and control risk
  • Documentation pitfalls
  • Design transfer
  • Design review
  • Design verification and validation
  • Close project or phase

Would you prefer a course held on your premises?

We are naturally happy to hold courses on your premises. Simply contact us to discuss your requirements.

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