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.
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:
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:
Don Hurd
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 …
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