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Software Development Under IEC 62304
The main focus will be on presenting tips and techniques for the practical application of the standard. Each phase in the development lifecycle will be discussed along with how the deliverables required can be created, maintained, and evolved to meet regulatory requirements.
- Planning
- Risk Management
- Architecture & Design
- Implementation and Unit verification/acceptance
- Integration & integration testing
- Software system testing
- Release
- Maintenance
- CM & change control
Overview of the webinar
ANSI/AAMI/IEC 62304 is a Recognized Consensus Standard by the US FDA and a harmonized standard in the EU. This means that compliance with it provides a presumption of conformity to the requirements within those jurisdictions. Many software developers see the standard, though, as imposing a “waterfall” development methodology; however, this is not the intent
Who should attend?
- Software Developer
- Software engineer
- System Engineer
- Project Manager
- Software Quality Assurance
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
Faculty - Mr.Donald (Don) Hurd
Don Hurd has over 35 years of experience in supporting the development of applications of or containing software in regulated industries, the last 20 in medical devices. With his diverse background, Mr. Hurd provides a unique insight into driving product quality and ensuring the 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 specializing in serving 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.