Usability Engineering in IEC 62366-1:2015 - Implementing the New Standard

Website http://www.onlinecompliancepanel.com/webinar/IES-STANDARDS-501195/JAN-2016-ES-OURGLOCAL | Edit Freely

Category Medical Device Compliance, Rules and Regulations, International Electrotechnical Commission, IEC Standards, Medical Device Manufacturers, United State National Committee of International Electrotechnical Commission, USNCIEC, New IEC Standards

Deadline: January 18, 2016 | Date: January 19, 2016

Venue/Country: online Webinar, U.S.A

Updated: 2016-01-07 16:38:27 (GMT+9)

Call For Papers - CFP

IEC Standards

Instructor: Daniel O'Leary

Product ID: 501195

Level: Intermediate

Description

This audio conference provides the explanation you need to help implement the new IEC 62366-1:2015 standard. It provides details on the new concepts, highlights the many revised definitions, and provides a conceptual model to help you understand the approach. For example, the audio conference uses examples to illustrate use error and its relationship to hazards and harms.

Objectives of the Presentation

The regulatory status of the new standard

The many revised definitions

The new concepts of formative and summative evaluation

The inputs to the User Interface Specification

The elements of the User Interface Evaluation Plan

The application of the evaluation plan to the design, demonstrating safety

Why Should you Attend

Medical device manufacturers need to stay current with the changing standards. This is particularly important for products with the CE Mark; the technical file or design dossier should include information on the application of harmonized standards when they change. The changes in this standard are significant, and companies need to develop a strategy for the change.

In February 2015, the usability engineering standard, which had been in place for about eight years, became obsolete. The new version, IEC 62366-1:2015, has a very different structure. Medical device manufacturers will need to implement this approach as part of the risk management system. For example, usability engineering applies to information for safety, as a risk control measure, to ensure users understand it.

Device manufacturers will transition to the new standard, meaning new procedures, additional training, and a new structure for the Usability Engineering File. Part of this transition includes using new concepts introduced in the standard. For example, the standard requires formative evaluation and summative evaluation, which are not common concepts in medical device design and production.

Who can Benefit

Design Engineering Managers

Interface designers, including software engineers

Technical writers providing instructions for users

Usability engineers

Risk managers

Professionals involved in complaint management and MDR reporting

For Registration -

http://www.onlinecompliancepanel.com/webinar/IES-STANDARDS-501195/JAN-2016-ES-OURGLOCAL

Note : Use coupon code 1371 and get 10% off on Registration