The main focus will be on presenting tips and techniques for 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. Topics include:
ANSI/AAMI/IEC 62366 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. Compliance with the standard helps both ensure a smooth path to market clearance and drives a safer product.
This webinar is intended for usability / human factors engineers, quality personnel, and project managers who manage projects with a user interface. The discussion will also help mechanical engineers, industrial designers, and software engineers working on GUIs.
A practical application of the standard is not always intuitive. There are some nuances that can lead to unnecessary and excessive work. This training session will discuss techniques and methods that have proven successful in better ensuring safe and effective products and compliant regulatory submissions.
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.