EU and US Design
Control Requirements

Course outline To stay active in the market there is a drive to continually introduce new medical device products, but how do we ensure new product designs are introduced in a complaint way to ISO 13485 and US FDA requirements and still meet customer requirements? This course will detail what is required to implement a quality system that incorporates the regulatory requirements for design controls for various classes of medical devices for both the European and United States markets. Project teams need to have an understanding of the key requirements for design control for key departments including QA, Regulatory, Development and importantly, Sales & Marketing. This course outlines the design process including terms: design planning, design input, design output, design review, verification, validation, transfer, changes and the creation of the essential design history file. The course will also detail the FDA QSIT inspection techniques for design control and provide a review of common audit findings.

Topics covered include:

  • European and US Design control requirements
    • Design & Development planning
    • Design inputs
    • Design outputs
    • Design reviews
    • Design verification and validation
    • Design transfer
    • Design changes
    • Design history file
  • QSIT inspection techniques for Design control and common FDA audit findings
  • Case study: Design control scenarios
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