Risk Management Under ISO 14971 Integrating Concepts From IEC 62304 and ANSI 62366

For most electro-mechanical medical devices that include software, ISO 14971 risk management on its own is unlikely to be enough. Regulators now expect risk management to reflect related standards, such as ANSI/AAMI/IEC 62304 for software and AAMI/IEC 62366 for usability, and IEC 60601-1 adds further risk management elements.

This 75-minute ISO 14971 risk management webinar demonstrates a method for integrating the risk-related requirements of 62304 software development and 62366 usability engineering into an overall risk management process that complies with ISO 14971.

The aim is a practical, coherent approach that produces one complete and consistent risk file rather than separate efforts for each standard.

• Explain why integrated risk management is needed for software-incorporating devices
• Identify the risk-related requirements of IEC 62304 and IEC 62366
• Recognize the additional risk aspects introduced by IEC 60601-1
• Integrate those requirements into an ISO 14971 risk management process
• Build a cohesive risk file and avoid managing risk in silos

• Why ISO 14971 alone is usually not enough for software-incorporating devices
• Risk management requirements in IEC 62304 (software development)
• Risk management requirements in IEC 62366 (usability engineering)
• Additional risk management aspects from IEC 60601-1
• A demonstrated method for integrating these requirements into an ISO 14971 process
• Building a complete, coherent risk file

Managing risk in silos leads to inefficient work and can leave gaps in the risk file. An integrated approach keeps the risk file cohesive and coherent while making sure the requirements of each relevant standard are addressed.

This session suits systems and development engineers from any discipline, engineering and project managers, quality staff on development projects, and people working in postmarket activities.

This webinar is intended for:

• Systems engineers
• Development engineers from any discipline
• Engineering managers
• Quality personnel associated with development projects
• Project managers
• Personnel engaged in postmarket activities will also benefit

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.