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 …
Construction Lending And Real Credit Administration: Evalua…
Dealing With Difficult People: At Work & In Life
Claude AI For CPAs & Finance Professionals: Best Practices …
Secrets Of The Staffing Fix - Solving The Employee Training…
Mastering the Prompt: How Every Professional Can Use AI to …
Using Copilot to Format Legal Documents in Microsoft Word
Setting SMART Goals & Leveraging Storytelling for Reporting
Eliminate Harmful And Unproductive Drama In The Workplace
Discover how Emotional Intelligence turns AI from a technic…
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
Introduction to Microsoft Power BI Dashboards
Excel + AI: The Smart User's Guide to Faster, Easier Work w…
Major cGMP Issues: FDA Concerns in 2026
Elevate Your Workplace Wellness: 10 Critical Wellness Facto…
Maximizing Productivity with ChatGPT: AI Solutions for HR, …
Excel - Pivot Tables - The Key To Modern Data Analysis and …
6-Hour Virtual Boot Camp on Microsoft Power BI
Managers/Supervisors: New Role, Same Team - How to Lead Wit…
HR Auditing - New Update on Important Issues for 2026
2-Hour Virtual Seminar on In-Person Onboarding Your New Hir…
Outlook - Master your Mailbox - Inbox Hero Inbox Zero
Managing Toxic Employees: Strategies For Leaders To Effecti…
Creating Employee Handbooks that Protect You and Support th…
Female to Female Hostility @Workplace: All you Need to Know
Project Management for administrative professionals
Tools for New Managers: Connecting with Employees to Optimi…
Launch Your Career: The Ultimate Guide for Emerging Profess…
California Meal and Rest Breaks: What You Don't Know Can Co…
Managing Difficult Employee Conversations
Thriving in a Hybrid Workplace: Keys to Leadership and Team…
The Perfect Storm Coming to Healthcare: Value Based Care Me…
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…