March 2, 2016 - March 24, 2016 | Singapore

SMF-MTIG MINDS series to be held in March 2016 is organized by Singapore Manufacturing Federation and supported by Singapore Workforce Development Agency (WDA). As a concluding part of the series, a workshop will provide comprehensive overview of human factors related to medical devices. The workshop covers regulatory requirements of FDA and EU, and the processes of applying human factors in design controls during the design of medical devices.

The topics of the series have been selected by SMF-MTIG with WDA and are listed below:

Date Duration Topic Speaker Organization
2 – 4 Mar 2016 3 days Implementing Design Control Requirements and Best Practices for Medical Devices Kate Leith, United States Oriel Stat A Matrix & ARQon
7 – 11 Mar 2016 5 days ISO13485 Lead Auditors Training, Plus USQSR & ISO13485:2016 Sharing Kate Leith, United States Oriel Stat A Matrix & ARQon
16 Mar 2016 1 day Singapore Product Registration routes & CSDT Preparation know-how 101 Grace Sun & Ching Hwee LEE, Singapore SMF-MTIG
18 Mar 2016 1 day Distribution and Business Strategy for Medical Device Companies Shikharesh Das, United States Ontogenix
22 – 24 Mar 2016 3 days Workshop on Human Factors Engineering for Medical Devices (AAMI/ANSI HE75 & IEC 62366) Michael Wiklund, United States UL

The SMF-MTIG MINDS series is honoured and delighted to have a panel of well-renowned speakers and trainers from Singapore and United States.

The agenda of the seminar is to learn how to plan usability and conduct verification and validation meeting AAMI / ANSI HE75 and IEC 62366. There will be hands-on exercises as well as real-life case studies illustrating the application of human factors to medical devices.

The topics of workshop on Human Factors Engineering include:

  •  Review of Current Regulations and Standards (focusing on IEC 62366)
  •  Differences between IEC requirements and FDA expectations
  •  Components of complete Human Factors Engineering Design History File
  •  Defining the Users, Use Scenarios, Use Environment and User Requirements
  •  Writing a Usability Specification
  •  Preparing a UI Validation Plan
  •  Identifying Use-Related Risks
  •  Designing Safe, Effective and Satisfying User Interfaces
  •  Conducting Usability Tests

UL as a committee member of this association recommends this course for professionals who already have a basic understanding of the framework of quality management systems, but need more in-depth information about the concepts, science, processes, methodologies and practical applications of human factors.

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