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 …
Project Management for Non-Project Managers - Scheduling yo…
Imposter Syndrome: How to Define, Understand & Shift Your E…
Contractor vs Employee: How to Tell the Difference and What…
FDA current recommendations related to timely initiation of…
Complying with the NEW I-9 and E-Verify Regulations - The I…
Impact Assessments For Supplier Change Notices
Implicit Bias: Becoming Aware of Your Inner Storyteller
The Federal Anti-Kickback Statute & Stark Law: What Physici…
Building an Effective Injury Management Process
Fatal Errors Employers Make When Updating Employee Handbook…
From Awareness to Action: Going Beyond the Law in Preventin…
Understanding the Changes Coming to NCCI's Experience Mod i…
Onboarding is NOT Orientation - How to Improve the New Empl…
From Awareness to Action: Going Beyond the Law in Preventin…
FDA Compliance and Clinical Trial Computer System Validation
5 Proven Ways To Engage & Retain Your Team Even During The …
Navigating New Paths: Unveiling Your Unique Abilities for a…
Form 1099 Update 2023: Latest Forms, Rules and Reporting Re…
Strategic Interviewing & Selection: Getting the Right Talen…
Excel - Unleashing the Full Potential of New Functions (Exc…
Amazing (!) AI Tools For Building Your Business
Implementing a Robust Change Control Program - Key Elements…
How to Conduct Annual Product Reviews to Achieve GMP Compli…
What Business Leaders Need to Know About Cybersecurity Prep…
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Understanding Social Security and Optimizing Retirement Inc…
Human Connection Leadership in 3D: Dare. Dream. Deliver.