Medical Device Software Development Under IEC 62304

ANSI/AAMI/IEC 62304 is a Recognized Consensus Standard by the US FDA and a harmonized standard in the EU. This means that compliance to it provides a presumption of conformity to the requirements within those jurisdictions. Not complying with the standard has shown to lead to longer regulatory review times and frequent rejections.

Why Should You Attend:

Software continues to get increasing amounts of attention by regulators and reviewers. Compliance with 62304 helps pave that pathway but 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. Not complying with the standard has been shown to lead to longer regulatory review times and frequent rejections.

IEC 62304 is both a recognized consensus standard by 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.

You 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 that haven’t worked on medical device projects.

Areas Covered in the Webinar:

• Why compliance to 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

Who Will Benefit:

This webinar is intended for software developers, software development managers, quality personnel associated with software development projects, and project managers who manage projects with a software development component from industries including medical device and IVD.