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 …
Understanding the Artificial Intelligence Landscape
Establishing Appropriate Quality Metrics and Key Performanc…
Holiday Stress and Loss: The Art of Stress Resilience in E…
Is Your Culture Working For or Against Your Success? If You…
OSHA Requirements for Supervisors, Project Leaders & HR - W…
Ultimate Persuasion Strategies! - Secret Influence Tools & …
Using High-Performance Coaching for Managers to Address Per…
Excel - 10 Key Worksheet Functions to Skyrocket Your Produc…
Transform Data into Insights: A Beginners Guide to Excel Pi…
Red flags that can render your OSHA Safety Program Complete…
Utilizing HR Metrics to Illustrate & Improve Human Resource…
The Human Element of Leadership in the Hybrid Work Experien…
How to Navigate Political Speech in the Workplace
What If Analysis Tools in Excel: Goal Seek, Solver, and Dat…
Project Management for administrative professionals
Mastering Year-End Payroll and Tax Compliance for 2024
How to Prepare For and Host a FDA Inspection and Respond to…
Eliminate Harmful And Unproductive Drama In The Workplace
3-Hour Virtual Seminar on Chat GPT for Project Management i…
The Anti-Kickback Statute: Enforcement and Recent Updates
5 Key Components of Good Manufacturing Practices to obtain …
FDA Technology Modernization Action Plan (TMAP) and Impact …
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Team Synergy: How to Harness Collective Intelligence to Max…
The Power Of Trust In The Workplace- Improving Your Career …
Managing Toxic & Other Employees Who Have Attitude Issues
Successful Strategies for FDA Expedited Pathways for Your D…
Protect Your Company With The End of the Year HR Checklist
Do's and Don'ts of Giving Effective Feedback for Performanc…
So, You’re Now the “Boss”: Essential Skills to Succeed as a…
Onboarding is NOT Orientation - How to Improve the New Empl…
2-Hour Virtual Seminar on the 6 Most Common Problems in FDA…
Construction Lending And Real Credit Administration: Evalua…
Improving Employee Engagement & Retention Through Stay Inte…
Building GMP Excellence: A Guide to Implementing Compliant …
Understanding cognitive load in medical device design
Human Error Reduction Techniques for Floor Supervisors
Excel Power Skills: Master Functions, Formulas, and Macros …
