Usability Principles for Medical Devices: Interpreting and Implementing IEC 62366

Why Should You Attend:

Both the U.S. FDA and the EU's MDR require consideration of use engineering / human factors engineering as part ofnew or changed product development, especially in R&D. Companies must be proactive in evaluating a device's interface inorder to design for almost intuitive use, reducing product risk, and increasing product safety. When it must be used and where such usage may not be required. When used, companies have often not provided the full documentation for the defined nine stages of use engineering to prove compliance and assist product engineers in refining the design to increase usability and reduce use risk.

Areas Covered in the Webinar:

• 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”
• 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
• Incorporation into the design and development (R&D) phase

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that need a repeatable methodology, and their in-house personnel trained in cGMP and MDr/CE-marking compliance. It will discuss and provide examples of ISO- and FDA/CGMP-compliant product use engineering / human factors templates. This applies to companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

• Senior management
• Regulatory Affairs
• Quality Assurance
• Production
• R&D and Engineering
• All personnel tasked with product develop, use / human factors / hazard reduction and problem solving

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 41 years experience in U.S. FDA-regulated industries, 27 years as head of his own consulting company. 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 including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. 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 ptublished numerous articles in peer reviewed journals, 5 chapters in the RAPS textbook on validation, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of UCLA.

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