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Outsourcing Software Development for Medical Devices
- Overview of software for medical devices
- Overview of the software lifecycle and brief introduction to IEC 62304 (and why it’s important)
- Qualifying and approving a supplier
- Software Development Planning
- Coordinating Risk Management & Usability Engineering
- Coordinating requirements
- Coordinating testing
- Monitoring the supplier
- Managing software releases
- Software Maintenance and Monitoring
Overview of the webinar
This webinar will discuss the skillsets to look for when outsourcing, how to know if the work is compliant (without having to be an expert in software development), how to manage outsourced development, and your responsibilities throughout the product lifecycle.
Who should attend?
- Corporate management
- Supplier quality management
- Project Manager
- Software Developer / Software engineer
- System Engineer
Why should you attend?
Software development for medical devices is considered a “critical process” by the regulatory bodies and the best path forward is using skilled software engineers who understand compliance requirements. Further, software development may require a broad range of skills ranging from embedded software to cloud-based applications.Many companies cannot maintain a staff that meets all the needs and look to outsource the process.It may be tempting to go with the lowest cost but this often leads to compliance issues.
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.