UL 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 Lin

Associate Engineering Manager, Greater China

MRAS, UL – Life & Health Science

Event 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 perspective

The 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 Overview
13:45-14:00 Break
14:00-15:15 Software Requirement from Regulatory Perspective
15:15-15:30 Break
15:30-16:00 Consideration of medical device design phase
16:00-17:00 Individual Discussion

Photo Credits: ul.com

CO-ORGANIZERS:

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