ResearchAndMarkets.com, a leading provider of market research services, has announced that the "4-Hour Virtual Seminar on Usability Principles for Medical Devices: Interpreting and Implementing IEC 62366" webinar has been added to its library.
IEC 62366-1's 9-Stage Model for Regulated Companies: Discover the Power of IEC 62366-1. Are you looking to take your product development and implementation to the next level? If this is the case, then we invite you to join our high-impact seminar, designed to provide your company with valuable insight on incorporating Use Engineering and Human Factors Engineering using the renowned IEC 62366-1 Framework..It is imperative to maximize product success while minimizing product risk. We will cover the basic methodology of IEC 62366-1 in depth, providing you with the essential knowledge you need to seamlessly integrate Use Engineering into important aspects of your business, such as R&D design control, risk management, validation, root cause analysis, CAPA/failure investigations, GMP auditing, and liability reduction..Make sure you are compliant, 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.. It is essential that you do not miss this golden opportunity to ensure your products are compliant with the latest standards while also improving user experience and safety.I believe that the secret to the success of a product is the intuitive way it can be used! Contrary to risk management, Use Engineering is not always a requirement, but its potential impact on product risk reduction, intuitive user experience, liability reduction, and recall prevention cannot be ignored. Witness the transformation of your product development process when you embrace this powerful tool under design control.The following are some of the reasons why you should attend:. The FDA and the EU's MDR require the consideration of Usability Engineering / Human Factors Engineering when developing a new product or updating an existing one.. Make sure you do not allow compliance to become a stumbling block in designing your device's interface. Instead, be proactive in evaluating the interface of your device and empower your team to create products that will delight your users.Learn how to harness the full potential of Use Engineering! Unravel the mystery behind the nine stages of Use Engineering, and find out how to provide foolproof documentation to demonstrate compliance with the use engineering processes. Provide your product engineers with the knowledge they need to refine designs in order to ensure optimal usability, risk reduction, and customer satisfaction.Topics covered in this course include:
Topics covered in this course include:
As the Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years' experience in U.S. FDA-regulated industries, including 22 years as an independent consultant, the speaker is known as John E. Lincoln. As a consultant, John has worked with companies of all sizes, from start-ups to Fortune 100 companies, in the U.S., Mexico, Canada, France, Germany, Sweden, China, and Taiwan.
In addition to quality assurance, regulatory affairs, QMS problem remediation, FDA responses, new/changed product 510(k)s, process, product, and equipment QMS, software validations, ISO 14971 product risk management files and reports, Design Control/Design History Files, Technical Files, CAPA systems and analysis, etc..In the past few years, he has held positions in Manufacturing Engineering, Quality Assurance, Quality and Regulatory Affairs, as well as Director and Vice President of R&D.. In addition, John has prior experience in the military, government, electronics, and aerospace sectors
In addition, John has prior experience in the military, government, electronics, and aerospace sectors
A number of his articles have been published in peer reviewed journals, as well as workshops and webinars on CAPA, 510(k), risk analysis/management, FDA/GMP audits, validation, root cause analysis, and many other topics. A graduate of UCLA, John writes a recurring column for the Journal of Validation Technology. For more information on this webinar, please visit https://www.researchandmarkets.com/r/9mg02w.

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