Software development for Medical Devices under IEC 62304
IEC 62304 is both a recognized consensus standard by the FDA and a harmonized standard in the EU; therefore, being compliant with the standard is the most expedient path forward for medical device products that are or contain software. IEC 62304 is also called out as a standard under the IEC 60601-1 umbrella and thus compliance to 62304 is also the best path through product safety testing (if applicable to your system). This webinar will identify the deliverables expected by the standard and provide some guidance on the content expected. Participants will learn about the rationale behind the requirements and how those are applied to the deliverables. Many software developers see the standard as imposing a “waterfall” development methodology; however, this is not the intent and we’ll discuss how other methods can be applied. Further, there are a few “twists” that tend to confuse software developers who haven’t worked on medical device projects.Learning ObjectivesOverview 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 softwareWho Should AttendSoftware/firmware developersProject managers Engineering managementWhy Should You AttendA 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) submissionsCourse Outline:Why compliance with 62304 is a good idea Classes of SoftwareWaterfall -v- AgilePlanning a projectDeveloping requirementsSOUP Managing software-based risksDesign documentation Unit-level processes and documents IntegrationTestingRelease Software CMMaintenanceDealing with “legacy” softwareTrends in the industry
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IEC 62304 is both a recognized consensus standard by the FDA and a harmonized standard in the EU; therefore, being compliant with the standard is the most expedient path forward for medical device products that are or contain software. IEC 62304 is also called out as a standard under the IEC 60601-1 umbrella and thus compliance to 62304 is also the best path through product safety testing (if applicable to your system). This webinar will identify the deliverables expected by the standard and provide some guidance on the content expected.
Participants will learn about the rationale behind the requirements and how those are applied to the deliverables. Many software developers see the standard as imposing a “waterfall” development methodology; however, this is not the intent and we’ll discuss how other methods can be applied. Further, there are a few “twists” that tend to confuse software developers who haven’t worked on medical device projects.
Learning Objectives
- 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
Who Should Attend
- Software/firmware developers
- Project managers
- Engineering management
Why Should You Attend
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:
- Why compliance with 62304 is a good idea
- Classes of Software
- Waterfall -v- Agile
- Planning a project
- Developing requirements
- SOUP
- Managing software-based risks
- Design documentation
- Unit-level processes and documents
- Integration
- Testing
- Release
- Software CM
- Maintenance
- Dealing with “legacy” software
- Trends in the industry