Speaker Profile
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 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.
Don Hurd
May 23 2024
01 : 00 PM EST
60 Minutes
Software development for Medical Devices under IEC 62304
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 ..
Don Hurd
August 27 2024
01 : 00 PM EST
60 Minutes
Outsourcing Software development for Medical Devices
Many companies do not want to invest in building a software team and outsource the software development efforts for their medical device. Selecting the right development company can make or break your project. Even after selecting your partner, you still need to manage them. We’ll give a high-level overview of the software development process and what you need to know in order to ensure your sof..
Don Hurd
September 26 2024
01 : 00 PM EST
60 Minutes
Applying Risk-based Approaches to Processes Under the Quality Management System
Just about every process in the QMS can be driven through risk-based thinking. Creating a simple and effective plan is key to a successful application. This discussion will outline specific proven approaches to specific processes, ensuring both a rigorous approach and one that is acceptable to auditors/inspectors.Areas Covered The “big” ones: purchasing, training, computer system validationOthers: Aud..
Don Hurd
Recorded Webinar
60 Minutes
Complying with 21 CFR 11 for Electronic Records/Electronic Signatures
21 CFR Part 11 was promulgated in 1979 to address a gaping hole in the regulations regarding the use of electronic records and electronic signatures. The rule was, by FDA’s admission later, confusing and challenging. Learning ObjectivesOverview of 21 CFR Part 11Explain the concepts and rationale behind the rulesDiscuss the practical application of the rule Consider challenges with the ruleWho Sh..