System Engineering - Your Ideas Consulting

System Engineering for Medical Device and In Vitro Diagnostic Products

Does your product require the integration of multiple disciplines, development sites e.g. in different parts of the globe, also integrating vendors and also to be compliant in a regulatory environment for worldwide commercialization?
Did you ever feel that a system/ product may consist of more than its pieces?
Is the predictability of later stage project schedules a topic for you?

Your system engineering processes and deliverables are the key success element for your medical device/ IVD product development, serving the needs of all participating groups and disciplines, and leading to a predictable project outcome with a successful commercialization.

Course Objectives for 2 days of training

• Learn about system engineering role models, processes and deliverables.
  

• Understand the V-model as simple tool to define ownership, document layers and V&V responsibilities.
  

• Get insight into critical processes of your product development out of workshops and case examples.
  

• Discuss dependencies and interfaces between critical system engineering processes.
  

• Set up a traceability structure for your specific product.
  

• Exercise: Product design in an interdisciplinary environment.
  

• Exercise: Problem solving in an interdisciplinary environment.
  

• Access your organization regarding critical processes of system engineering.
  

Optional course extension: Apply the content learned on your products/ your environment and create respective document templates.

Topics

• Role models in medical device companies
  

• Process maturity
  

• Interdisciplinary teams
  

• V Model
  

• Functional system specification
  

• Product scenarios/ visions
  

• Requirements management
  

• Risk management
  

• Configuration management
  

• Verification and Validation
  

• Interfacing of Processes
  

• Interfacing of SE and PM
  

• Traceability Models
  

• V&V layers, ownership and scope
  

• Management of changes
  

• Regulatory compliance
  

Who Should Attend

Young engineers and all team members participating in an interdisciplinary medical device product development, responsible to built a robust compliant environment e.g. project management, system engineers; software, labeling, assay development, reagent/ instrument/ disposable manufacturing, service, quality assurance and regulatory affairs.