UL Symposium: An Overview of Medical Device Regulation | Peatixtag:peatix.com,2011:12019-10-31T01:38:53+08:00PeatixKairos ASEANUL Symposium: An Overview of Medical Device Regulationtag:peatix.com,2015:event-929172015-08-18T12:30:00SGT2015-08-18T12:30:00SGTUL Life & Health Science provides expertise for the Medical Device industry and offers values from product concept through commercialization. UL's in-depth knowledge in regulatory issues enables them to provide actionable insights to help customers achieve compliance in all of their target markets.Speaker:Tim LinAssociate Engineering Manager, Greater ChinaMRAS, UL – Life & Health ScienceEvent Summary:I. Global Regulatory Overview (Opening)A medical device product is designed and manufactured based on intended function. It is a fruit born through long period of intensive research and experimenting. However, researchers may overlook the importance of commercialization – Selling to different countries. This unintended negligence will result in delay of market launch/product realization and often in the medicalindustry, opportunity comes only once. The speaker will be covering on the overall international regulation governing the respective market access.II. Software Requirement from Regulatory perspectiveThe speaker will be delivering basic concerns of software including consideration from the regulatory authorities. With the experience of working with various start-ups and incubation center, the speaker will be sharing on a case study using Wearable Device to illustrate the Product Development Life cycle correlation to software and risk management. This will be helpful to existing medical device start-ups which eventually will have to submit their products for regulatoryapprovals.III. Consideration of Medical Device Design Phase (Closing)The speaker will be emphasize the importance of the design phase; linking the global regulatory overview to risk management and the pitfalls for overlooking it.IV. Individual Discussion (Q&A)We welcome questions from the floor and this will provide an environment where all can learn together. In addition, we will conduct a survey to understand the more popular topics from the ecosystem.Event Schedule:13:00-13:45 Global Regulatory Overview13:45-14:00 Break14:00-15:15 Software Requirement from Regulatory Perspective15:15-15:30 Break15:30-16:00 Consideration of medical device design phase16:00-17:00 Individual DiscussionPhoto Credits: ul.comORGANIZERS:SUPPORTING PARTNER:_________________________________________________________________ About
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entrepreneurs and businesses.About Diagnostics Development HubThe Diagnostics Development (DxD) Hub is a national initiative led by the Agency for Science and Technology Research (A*STAR), through its commercialization division ETPL, with the aim to fast track the transformation of diagnostics-related IPs into clinically validated and "registration ready" diagnostic devices for adoption by start-ups, SMEs and MNCs.Updatestag:peatix.com,2015-06-04 06:49:342015-06-04 06:49:34The event description was updated. Diff#95759Updatestag:peatix.com,2015-06-04 06:48:482015-06-04 06:48:48The event description was updated. Diff#95758Updatestag:peatix.com,2015-06-04 06:45:032015-06-04 06:45:03The event description was updated. Diff#95756Updatestag:peatix.com,2015-06-04 06:42:542015-06-04 06:42:54The event description was updated. Diff#95755Updatestag:peatix.com,2015-06-04 06:40:522015-06-04 06:40:52The event description was updated. Diff#95754Updatestag:peatix.com,2015-06-04 06:39:282015-06-04 06:39:28The event description was updated. Diff#95752Updatestag:peatix.com,2015-06-04 06:35:302015-06-04 06:35:30The event description was updated. Diff#95751Updatestag:peatix.com,2015-06-04 06:34:342015-06-04 06:34:34The event description was updated. Diff#95750Updatestag:peatix.com,2015-06-03 06:45:522015-06-03 06:45:52The event description was updated. Diff#95493Updatestag:peatix.com,2015-06-03 06:45:292015-06-03 06:45:29The event description was updated. Diff#95492Updatestag:peatix.com,2015-06-03 06:44:372015-06-03 06:44:37The event description was updated. Diff#95491Updatestag:peatix.com,2015-06-03 06:44:132015-06-03 06:44:13The event description was updated. Diff#95490Updatestag:peatix.com,2015-06-03 06:43:482015-06-03 06:43:48The event description was updated. Diff#95489Updatestag:peatix.com,2015-06-03 06:43:192015-06-03 06:43:19The event description was updated. Diff#95488Updatestag:peatix.com,2015-06-03 06:42:512015-06-03 06:42:51The event description was updated. Diff#95487Updatestag:peatix.com,2015-06-03 06:41:492015-06-03 06:41:49The event description was updated. Diff#95486