Page 21 - MedTech 1920_29Oct
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SINGAPORE MEDTECH DIRECTORY 2019/2020
EMC Lead/L3 Reviewer introduced about 30 attendees to electrical safety standard of IEC 60601-1-11 with its structure and global requirements for home healthcare medical devices. Focus on electrical safety protection for these medical devices. With awareness of protection against the electrical hazards, the improved safety for medical devices is applied regardless of whether the medical electrical equipment or medical electrical system is intended for use by a lay operator or by trained healthcare personnel.
Medical Device Software Life Cycle Process, SaMD consideration and Cybersecurity
29th May 2019, Wednesday NTU@one-north
Mr Tim Lin, Senior RA/QA Consultant presented a regulatory overview of IEC 62304, comprising 5 key elements to form
complete life cycle. Guidance publication of IEC 62304 in latest IMDRF has reaffirmed the strong relationship with regulatory scheme of Software as Medical Device, SaMD.
In this one-day seminar, more than 50 attendees understand the essential role of UL 2900 in fulfilling cybersecurity requirements, as well as the core of Clinical Evaluation of Software as Medical Device, SaMD published by US FDA. The combination of these 3 essential standard and guidance are crucial to have a completely effective SaMD life cycle from pre market to post market perspective
SMF MTIG Regulatory Services Sub committee Chairperson delivered her welcome address at the training workshop
co organised by Medical Technology Industry Group of Singapore Manufacturing Federation (SMF MTIG), Emergo, a UL Company, Standards Development Organisation of Singapore Manufacturing Federation (SMF SDO) and JUMSTART.
Mr Tim Lin, Senior RA/QA Consultant presented to more than 50 attendees from medical technology companies.
A group photo of about 30 attendees for
the training workshop co organised by UL International and Medical Technology Industry Group of Singapore Manufacturing Federation, SMF MTIG.
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