- Overview of the standard
- Provide a practical application of the concepts
- Discuss integration with other applicable standards (e.g., ISO 14971, IEC 62366) and guidance (FDA)
- Considerations for legacy software
A practical application of the standard is not always intuitive. The standard gives the impression, to many, that it enforces a particular methodology, but the standard can be adopted irrespective of the development methodology. This training session will discuss techniques and methods that have proven successful in regulatory (and test lab) submissions
Course Outline:
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