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 …
ChatGPT and Project Management: Leveraging AI for Project M…
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
Practice Safe Stress ™: Preventing Burnout While Building R…
Rewiring Your Emotional Triggers: Leading with Clarity and …
AI, Jobs, and Skills: How HR Leaders Can Prepare Now for th…
The Age-Inclusive Workplace: How to Lead and Work Across Ge…
Pivot tables beginner to advanced + 20 advanced Pivot table…
Writing Effective Job Descriptions
HR Metrics and Analytics 2026- Update on Strategic Planning…
High-Impact Performance Management: Tools, Tactics & Coachi…
Validation Statistics for Non-Statisticians
Batch Record Review and Product Release
Human Factors Usability Studies Following ISO 62366 and FDA…
Best Practices for FDA Computer System Audit Preparation in…
Fire Without Fear: How to Legally Terminate an Employee
FDA Regulation of Artificial Intelligence/ Machine Learning
Empowering Conflict Resolution: Letting Go to Gain Control
The Importance of the first 5 seconds when presenting
Burnout to Fired-up : Recognizing and Preventing Burnout in…
Do's and Don'ts of Giving Effective Feedback for Performanc…
Managing Toxic & Other Employees Who Have Attitude Issues
Reduce Stress in the Workplace: Effective Ways to Handle Co…
Better Mind, Better Life: Unlocking Your Full Potential
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA…
Why EBITDA Doesn't Spell Cash Flow and What Does?
Fostering a Culture of Respect: Eliminating Gossip, Rumour…
Human Error Trends as AI Enters GMP Operations: What QA Lea…