Discover the Power of IEC 62366-1's 9-Stage Model for Regulated Companies. Are you ready to take your product development and implementation to the next level? Join our high-impact seminar, designed to equip your company with valuable guidance on incorporating Use Engineering / Human Factors Engineering using the acclaimed IEC 62366-1 framework.
Maximize Product Success - Minimize Product Risk! Our expert-led event will dive deep into IEC 62366-1's basic methodology, providing you with essential knowledge to seamlessly integrate Use Engineering into crucial aspects of your business, including R&D design control, risk management, validation, root cause analysis, CAPA / failure investigations, GMP auditing, and liability reduction.
Stay Compliant, Stay Ahead! Stay ahead of regulatory requirements by gaining comprehensive insights into IEC 62366-2's recommended implementation considerations, with a primary focus on IEC 62366-1. Don't miss this golden opportunity to ensure your products comply with the latest standards while enhancing user experience and safety.
The Secret to Success: Intuitive Product Use! Unlike risk management, Use Engineering isn't always a must, but its potential impact on product risk reduction, intuitive user experience, liability reduction, and recall prevention is undeniable. Embrace this powerful tool under design control and witness the transformation of your product development process.
Harness the Full Potential of Use Engineering! Unravel the mystery behind the nine stages of Use Engineering, and learn how to provide foolproof documentation to demonstrate compliance. Equip your product engineers with the knowledge to refine designs for optimal usability, risk reduction, and customer satisfaction.
Maximize Product Success - Minimize Product Risk! Our expert-led event will dive deep into IEC 62366-1's basic methodology, providing you with essential knowledge to seamlessly integrate Use Engineering into crucial aspects of your business, including R&D design control, risk management, validation, root cause analysis, CAPA / failure investigations, GMP auditing, and liability reduction.
Stay Compliant, Stay Ahead! Stay ahead of regulatory requirements by gaining comprehensive insights into IEC 62366-2's recommended implementation considerations, with a primary focus on IEC 62366-1. Don't miss this golden opportunity to ensure your products comply with the latest standards while enhancing user experience and safety.
The Secret to Success: Intuitive Product Use! Unlike risk management, Use Engineering isn't always a must, but its potential impact on product risk reduction, intuitive user experience, liability reduction, and recall prevention is undeniable. Embrace this powerful tool under design control and witness the transformation of your product development process.
Why Should You Attend:
Both the U.S. FDA and the EU's MDR mandate the consideration of Use Engineering / Human Factors Engineering for new or updated products. Don't let compliance become a stumbling block; instead, be proactive in evaluating your device's interface and empower your team to design products that users will love.Harness the Full Potential of Use Engineering! Unravel the mystery behind the nine stages of Use Engineering, and learn how to provide foolproof documentation to demonstrate compliance. Equip your product engineers with the knowledge to refine designs for optimal usability, risk reduction, and customer satisfaction.
Agenda
- IEC 62366-1 and -2 overview
- The 9 key requirements of IEC 62366-1 and -2
- UOUP
- Part 1 focuses on 'what', Part 2 on 'how'
- The key is the' Interface' - What is it?
- When and how to incorporate into product development
- Planning
- A clearly defined process for US cGMPs and ISO 13485 compliance
- Importance of concurrent risk management
Speaker
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years’ experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new/changed product 510(k)s, process/product/equipment QMS and software validations, ISO 14971 product risk management files/reports, Design Control/Design History Files, Technical Files, CAPA systems and analysis.He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis/management, FDA/GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.
