Software development for Medical Devices under IEC 62304
Don Hurd has over 35 years of experience in supporting the development of applications of or containing software in regulated industries, the last 17 in medical devices. With his diverse background, Mr. Hurd provides a unique insight into driving product quality and ensuring high productivity of development organizations. Mr. Hurd is currently the Vice President of Quality and Validation Services for The Realtime Group, a contract R&D firm specialized in serving the regulated industries, primarily medical devices. In this role, Mr. Hurd led the company to certification in both ISO 9001 and ISO 13485, maintaining certification for nearly 15 years. In his role at Realtime, Mr. Hurd supports clients in efforts ranging from Quality Management System development, deployment, and remediation; product and development quality planning; verification and validation of products, product software, and non-product software; supplier qualification, approval, and management; transitioning product from development to manufacturing; supporting post-market vigilance/surveillance, and interfacing with ISO auditors and FDA inspectors. Mr. Hurd has been an ASQ Certified Quality Auditor since 2009. Mr. Hurd is active in the ASQ Biomedical Division Discussion Group, ASQ Audit Special Interest Group, and bionorthTX, holding leadership positions in each.
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
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$200.00
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