ANSI/AAMI/IEC 62304 is a recognized Consensus Standard by the US FDA and a harmonized standard in the EU. This means, being compliant 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
The key learning objectives would be to provide an overview of the standard and a practical application of the concepts irrespective of the development methodology of choice. The training would provide guidance on adapting the standard to current methodologies.
A practical application of the standard is not always intuitive. The standard, to many, gives the impression 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.
The main focus will be on the presenting tips and techniques for practical application of the standard. Each phase in the development lifecycle will be discussed along with how deliverables required can be created, maintained, and evolved to meet regulatory requirements.
Don Hurd has over 35 years of experience in supporting the development of applications or containing software in regulated industries, the last 17 in medical devices. With his diverse background, Don provides a unique insight into driving product quality and ensuring the high productivity of development organizations. He is currently the vice president of Quality and Validation Services for The Realtime Group, a contract R&D firm that specializes 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, he 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. He has been an ASQ certified quality auditor since 2009. He is active in the ASQ Biomedical Division Discussion Group, ASQ Audit Special Interest Group, and bionorthTX, holding leadership positions in each of them.