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

Risk Management under ISO 14971 alone is unlikely to be sufficient for most electro-mechanical, software-incorporating medical devices. The current requirements by regulatory bodies incorporate risk management concepts driven by relevant standards such as ANSI/AAMI/IEC 62304 for software and AAMI/IEC 62366 for usability. Similarly, IEC 60601-1 adds further risk management aspects.

WHY SHOULD YOU ATTEND?

An integrated approach to risk management, incorporating all these aspects, ensures a comprehensive, cohesive, and coherent risk file while ensuring requirements from these relevant standards are addressed. Attempting to manage risk in “silos” would lead to inefficient operations and possibly an incomplete risk file.

AREA COVERED

A method to integrate risk management-related requirements from 62304 (software development) and 62366 (usability engineering) will be demonstrated.

LEARNING OBJECTIVES

The key learning objectives would be to provide techniques for a practical and coherent approach to risk management by incorporating the requirements from 62304 and 62366 into the overall risk management process compliant with ISO 14971.

WHO WILL BENEFIT?

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