IEC 62304 for Medical Device Software Development: Steps to Compliance
Overview:
IEC62304 is a internationally recognized software lifecycle standard. The risk dependent activities and documentation requirements necessary for compliance with this document will be explained.
Questions like:
- How much detail is required in the requirement specification?
- What is a software unit?
- How can integration testing be performed without test harnesses?
will be answered. Practical guidance on how to employ a streamlined but yet compliant development process will be given.
Why should you attend:
This webinar will explain basic design control concepts and the criticality dependent requirements for software development. Software specification, architectures and resulting design documentation will be discussed, as well as practical tips on how to streamline the development process and minimize the regulatory burden.
Areas Covered in the Session:
- Software requirements specification
- How to write meaningful requirements
- Software architectures
- Multi software system implementation
- Software design documentation
- Requirements traceability
- Software unit and integration testing
- Software testing in real-time systems
- Software tools
- SOUP (software of unknown providence)
Who Will Benefit:
- Project Management
- Regulatory / Quality Control
- Software Engineering
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