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 …
California Meal and Rest Breaks: What You Dont Know Can Cos…
Responding to EEOC Discrimination Charges-What's Your Busin…
Implementing an Effective Human Error Reduction Program
Conflict Resolution - Prevent, De-escalate, Resolve
When Employees Travel: Wage and Expense Rules Employers Mus…
With Mandatory Paid Leave Gaining Ground Is It Time To Do A…
Female to Female Hostility @Workplace: All you Need to Know
Form 1099-MISC and 1099-NEC Compliance Update 2024
Validation Statistics for Non-Statisticians
The Totally Organized Professional Is All About Outcomes
Why EBITDA Doesn't Spell Cash Flow and What Does
GAMP5, Second Edition and Alignment with Computer Software …
Project Management for Non-Project Managers - Scheduling yo…
Sunshine Act Reporting - Clarification for Clinical Research
Understanding the Math of HR… So You Can Show How HR Impact…
FFIEC BSA/AML Examination Manual: What Compliance Officers …
How to Address ISO's New Climate Change Requirements
I-9 Audits: Strengthening Your Immigration Compliance Strat…
Re-imagine Finance & Accounting Made Simple. Three Webinars…
Stay Interviews: A Powerful and Low-Cost Employee Engagemen…
How To Conduct An Internal Harassment And Bullying Investig…
Effective Onboarding: How to Welcome, Engage, and Retain Ne…
Managing Toxic & Other Employees Who Have Attitude Issues
Analytical Method Validation Under Good Laboratory Practic…
Do's and Don'ts of Documenting Employee Behaviour, Performa…
Do's and Don'ts of Giving Effective Feedback for Performanc…
Onboarding New Hires: Leverage the Potential of Artificial …
Project Management for HR, Administrative Professionals, an…
Tattoos, hijabs, piercings, and pink hair: The challenges …
Using Behavior Based Interviewing for Finding the Best Matc…
How to Document Employee Discussions and Why it is Important
Stressed Out: How to Handle Conflict, Difficult People and …
Harassment, Bullying, Gossip, Confrontational and Disruptiv…
Best Practices for Working With Vendors and Suppliers
Understanding the Artificial Intelligence Landscape
Marketing to Medicare or Medicaid Beneficiaries - What You …
Accounting For Non Accountants : Debit, Credits And Financi…
Principles & Practices for the Cybersecurity of Legacy Medi…
Independent Contractor vs. Employee New Rule Issued by The …
Ultimate Persuasion Strategies! - Secret Influence Tools & …
Kicking your Employee Retention Efforts into Overdrive: Sta…