Subscribe NewsletterIEC 62304 for Medical Device Software Development: Steps to Compliance
RAPS Approved. Earn 1.00 RAC Points
RAPS Approved. Earn 1.00 RAC Points
Product Id
:
600748
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:
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:
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?
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)
- Project Management
- Regulatory / Quality Control
- Software Engineering