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 …
Empowering Conflict Resolution: Letting Go to Gain Control
Developing an Agile Workforce with Emotional Intelligence (…
FDA Regulation of Artificial Intelligence/ Machine Learning
Compliance Under Fire: Navigating I9 Immigration Raids & …
How to Give Corrective Feedback: The C.A.R.E. Model - Elimi…
Human Error Reduction Techniques for Floor Supervisors
How To Conduct An Internal Harassment And Bullying Investig…
Secrets Of Psychology - Why People Do The Things They Do
FDA Compliance And Laboratory Computer System Validation
Leadership: Strategic Planning and Decision Making
Polish your Presence on Linkedin - The Powerful Profile
Marketing to Medicare or Medicaid Beneficiaries - What You …
Human Factors Usability Studies Following ISO 62366 and FDA…
Leveraging Artificial Intelligence in HR
Bootcamp for New Managers and Supervisors: Develop These Es…
Utilizing A Proven Process When Conducting Sensitive, Inter…
Understand the Different Contexts in DAX, The Filter Contex…
Understanding and Analyzing Financial Statements
HR Metrics and Analytics 2025 - Update on Strategic Plannin…
The Importance of Storytelling in Project Management
Defensive Documentation: Protecting Your Organization from …
Topic Name/Course Title Leading a Project and Team in Stres…
Power Bi - Turn Bad Data Into Great Data In Minutes
OSHA Reporting: What are OSHA's Reporting Requirements?
Onboarding is NOT Orientation - How to Improve the New Empl…
Copilot and HR: An Introduction for HR Professionals
Establishing Appropriate Quality Metrics and Key Performanc…
How to Write Effective Audit Observations: The Principles f…
Basic Accounting and Finance for Human Resources Profession…
EBIT/EBITDA - Understanding Your Profit and Loss Statement-…
FDA Audit Best Practices - Do's and Don'ts
Handbook Overhaul 2026: Compliance, OBBB Act & Beyond
FDA Technology Modernization Action Plan (TMAP) and Impact …
Stress, Change And Team Resilience Through Humor: An Intera…
Controller Challenges in Changing Times: New Roles as Strat…
The Importance of the first 5 seconds when presenting
Excel Spreadsheets; Develop and Validate for 21 CFR Part 11…
Sunshine Act Reporting - Clarification for Clinical Research
How to Prepare For and Host a FDA Inspection and Respond to…
From Chaos To Calm: How to Eliminate Drama and Boost Workpl…
Managing Toxic Employees: Strategies For Leaders To Effecti…