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.
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.
A method to integrate risk management-related requirements from 62304 (software development) and 62366 (usability engineering) will be demonstrated.
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.
This webinar is intended for:
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.
A method to integrate risk management-related requirements from 62304 (software development) and 62366 (usability engineering) will be demonstrated.
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.
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 …
Effective Communication Skills It’s Not What You Say, But H…
Trust in Leadership: Building and Maintaining Trust as a Le…
2026 Handbook Overhaul: Navigating Critical Updates! Does t…
Mastering Performance Management: Strategies for Continuous…
From Concept to Creation: Strategies for Cultivating Workpl…
2025 EEOC & Employers: Investigating Claims of Harassment …
How to Reduce Human Error in a GMP Manufacturing Floor
The Importance of the first 5 seconds when presenting
Trump’s Executive Orders on DEI and Disparate Impact, and t…
How Accountants Can Use Chat GPT Effectively
Project Management for administrative professionals
Pivot tables beginner to advanced + 20 advanced Pivot table…
The OBBBA Era & Beyond: Your 2025 Playbook for Compliance a…
Changing Behavior: Why Rewards and Punishments Often Aren't…
Launch Your Career: The Ultimate Guide for Emerging Profess…
ChatGPT Unlocked: A Beginner’s Guide to AI and ChatGPT
Managing Toxic & Other Employees Who Have Attitude Issues
Employee Handbooks: 2025 Critical Issues
ChatGPT and Project Management: Leveraging AI for Project M…
How to Write Contracts for Procurement Professionals
Retention Starts Here: Stop Losing Your Critical Talent and…
6-Hour Virtual Boot Camp on Microsoft Power BI