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 …
2025 Handbook Overhaul: Navigating Critical Updates! Federa…
Dealing With Difficult People In Life & Work
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Copilot and HR: An Introduction for HR Professionals
Beat Workplace Burnout: 10 Proven Techniques to Manage Your…
Workplace Investigations Uncovered: Best Practices and Stra…
Employers Should Prepare for Immigration Raids in 2025! Thi…
Managing Toxic Employees: Strategies For Leaders To Effecti…
Keys to Captivating an Audience: Informing and Inspiring t…
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Understanding Artificial Intelligence (AI) & using Chat GPT
Transform Data into Insights: A Beginners Guide to Excel Pi…
Empowering Conflict Resolution: Letting Go to Gain Control
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
Bootcamp for New Managers and Supervisors: Develop These Es…
Project Management for administrative professionals
Negotiating Skills For Professional Results - Winning Strat…
How to Write Effective Audit Observations: The Principles f…
How to Use ChatGPT to Write Employee Evaluations
Power BI - Getting Started Building Reports and Dashboards
3-Hour Virtual Boot Camp on Easier Excel Automation with VB…
Onboarding is NOT Orientation - How to Improve the New Empl…
How to Conduct Exit Interviews - Implementing and Enhancing…
Onboarding Best Practices for 2025: Proven Strategies to Po…
Form W-9 Compliance: TIN Verification, B Notices, and Avoid…
The Five Cs Of Commercial Credit: The Basic Elements Of Cre…
2025 EEOC & Employers: Investigating Claims of Harassment …
2-Hour Virtual Seminar on How to Conduct an Internal Harass…