- Knowledge of the European regulatory requirements (Medical Directive 2007/47 / EEC) and US (FDA) related to the development and software validation.
- Identify and understand normative documents or useful guides to claim conformance to regulatory requirements.
- Know how to implement the quality management principles for the development of software medical devices.
- Welcome and Introductions
- The Regulation: the regulatory provisions relating to the development and software validation
- Introduction to the US and European requirements
- Introduction to standards and guides available to industry to address regulatory requirements
- Planning software development
- Defining Requirements (System Input Data)
- Building & Design of software
- Implementation of a risk management process applied to software
- Testing carried out on the software
- Configuration and cyber Security management
- Software Maintenance and resolution of software issues: how to apply a corrective and preventive actions process?
- Course evaluation, synthesis and conclusions