Usability Principles for Medical Devices: Interpreting and Implementing IEC 62366

This webinar will provide valuable guidance to regulated companies in development and implementation of Use Engineering/Human Factors Engineering using the 9 stage model in IEC 62366-1. IEC 62366-2 on recommended implementation considerations will be briefly considered, with the focus on IEC 62366-1, the basic methodology. the webinar willshow when and how these tools are incorporated into R&D design control, risk management, validation, root cause analysis, CAPA/falure investigations, GMP auditing, and liability reduction. Unlike risk management, use engineering may not always be necessary, depending upon the user interface under review. Use engineering is designed to reduce product risk, increase intuitive product use, reduce liability, and less chance of recalls.

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