Registration Date |
: | 11 Apr 2019 05:15PM to 25 Apr 2019 03:00PM |
SMF Member Fee |
: | $107.00 |
GS1 Member Fee |
: | $107.00 |
Non-Member Fee |
: | $214.00 |
Event Type |
: | Workshops |
Industry Group |
: | Medical Technology |
Contact Person |
: | Cherie Ong |
The presenter, Mr. Merrick Kossack, Research Director will introduce the audience to usability engineering (UE) of software as a medical device (SaMD) as the key highlight of Human Factors Engineering (HFE) 2019, demonstrating the advantages of optimizing device design through application of HFE/UE. With improved safety from the application of HFE/UE, the likelihood of the incurring expenses associated with product recalls or liability is reduced; and when HFE/UE approaches are used during the design development process, particularly if the perspective of users is taken into account, the overall ease of use and appeal of a device can simultaneously be enhanced.
Attendees will learn about the constitution of software as a medical device, SaMD. They could also understand human factors and its relevance to SaMD development and importantly to interpret effectively about the regulatory guidance, including Medical Device Directive, MDD and US Food & Drug Administration, FDA related to SaMD.
At the end of the workshop, attendees will have a better understanding of use-related risk management activities for SaMD and apply Human Factors (UE) process to SaMD. They could have learned about the usability testing techniques for SaMD and demonstrate other considerations when developing SaMD.
Programme is tentative and is subject to change at the sole discretion of Singapore Manufacturing Federation. Should you require further information or assistance, kindly contact Ms Cherie Ong, DID: +65 6826 3039