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SINGAPORE MEDTECH DIRECTORY 2019/2020
About Training Workshop
Human Factors Engineering Workshop 2019
Usability Engineering of Software as a Medical Device (SaMD)
26th April 2019, Friday, 1 Day NTU@one-north
Presenter, Mr. Merrick Kossack, Research Director introduced 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.
More than 50 attendees learned 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 andUSFood&DrugAdministration,FDA related to SaMD.
At the end of the workshop, the attendees had 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.
Designing for Compliance to IEC 60601-1 3rd + Amendment 1 Edition Workshop 2019
8th May 2019, Wednesday, 1 Day
SMF Concourse Auditorium
UL presenters, Miss Lee Chen Chen, Program Manager/Regional Lead Reviewer and Mr Damien Ong, Lead Test Engineer/
Mr. Merrick Kossack presented to more than 50 attendees for the training workshop co organised by Emergo, a UL Company, Medical Technology Industry Group of Singapore Manufacturing Federation, SMF MTIG and JUMPSTART.
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