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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 a set of materials, with a course binder containing PowerPoint slide handouts and templates, and a book entitled “A Guide to the Project Management Body of Knowledge” (the PMBOK Guide).

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

  • Project management
  • Project models
  • Laws, standards, and regulations
  • Key elements of design control
  • The project model for the course
  • Creating a project charter
  • Identifying stakeholders

Day 2

  • Collect requirements
  • Define scope
  • System design
  • Product risk management
  • Plan verification and validation
  • Create WBS
  • Scheduling
  • Develop human resource plan
  • Project risk management

Day 3

  • Estimate cost
  • Develop project management plan
  • Design review
  • System decomposition
  • Execute, control and change

Day 4

  • Control schedule
  • Control scope
  • Control cost
  • Monitor risk
  • Design transfer
  • Verify scope and VVQ
  • Project close-out
  • Repetition

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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