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About

Starts

Apr 01, 2013, 08:50

Ends

Apr 02, 2013, 16:30

Location

Taiwan

SGS invites you to our:  SGS Global Medical Device Regulation Seminar - Taiwan

Join Medical Devices experts from across  EU, Canada, Japan, Korea, Brazil for an informative andinteractive two-day symposium focusing on the major challenges and opportunities you face today. The symposium will be held in Taiwan.

Our speakers will discuss a wide range of topics covering the updated global regulatory requirements for medical devices, including:

  • Understanding and the latest and future regulation requirements in EU             
  • Understanding and the latest regulation requirements in Brazil
  • Recent Developments in US FDA and Health Canada joint audits
  • Overview of regulatory system and recent updates in Korea
  • Overview of regulatory system and recent updates in Japan
  • Life-cycle management for MD software
  • EN 62366 Usability requirement for medical devices
  • The Clinical evaluation Requirement for medical devices
  • IEC 60601-1-8 alarm system Testing

They will share their industry wide experience and expertise with you. At the same time you will have the unique opportunity to network with other medical devices sector professionals. Attending the symposium will give you a new perspective on medical devices and how to approach the issues your organization faces on a daily basis.

Date: 1st-2nd, April, 2013 (Mon. - Tue.)

Venue: Fubon International Meeting Center in Taipei

Registrion Information:

To reserve your free space on the SGS Medical Devices Symposium please email your name, job title and organization name to: Quincy Cheng.  Please email your details by {28. Mar, 2013}.

If  you are the client of SGS, the first representative of your company is invited to attend the event free of charge. Should more than one person from your organization wish to attend the symposium, we ask that a contributory payment of {NTD 4,000} is made per additional attendee. If you are not the client of SGS, we ask that a contributory payment of {NTD 4,000} is made per attendee. Please provide a company invoicing address when reserving a second space.

Program

Day 1-1st April, 2013 (Monday)

timecontentspeaker
08:50 Welcome Wendell Chang, SSC, Taiwan Division manager, SGS
08:55 Introduction of participants
09:00 Understanding and the latest and future regulation requirements in EU-MDD/IVDD C. Jepson , SGS Global Manager – Medical Device, SGS UK , SGS
11:00 Coffee break
11:20 Understanding and the latest regulation requirements in Brazil Luis Lopes, Lead Auditor – Medical Device, SGS Brazil, SGS
12:20 Lunch
13:20 Recent Developments in US FDA and Health Canada joint audits C. Jepson, SGS Global Manager – Medical Device, SGS UK, SGS
14:00 Break
14:20 Overview of regulatory system and recent updates in Korea SoonGon Park, Country Business Manager for Systems & Services Certification SGS Korea, SGS
15:30 Overview of regulatory system and recent updates in Japan Naonori Inagaki, Medical Device P/L Manager. SGS Japan, SGS
16:30 Q&A
Day 2-2nd April, 2013 (Tuesday)
timecontentspeaker
09:20 Life-cycle management for MD software Chun-Chi Lin, Director of information engineering Dept., Chang Gung University
10:30 Coffee Break
10:50 EN 62366 Usability evaluation Benson Liao, Leader Auditor of Systems & Services Certification, SGS Taiwan
12:00 Lunch
13:00 Clinical evaluation of medical devices Dr.Yi-Wen Chu, General Manager, Efficient Pharmacy Management Corp.
15:00 Break
15:20 Alarm system requirements for medical devices Terence Hsieh, Department Manager of Reliability Laboratory, SGS
16:30 Q&A
A complimentary lunch will be available on both days.
Contact Information:

To learn more about the SGS Medical Devices Symposium, please contact:

Malta CHANG
t +886 2 2299 3279 Ext. 1259

For Symposium reservations, please contact:

Malta CHANG
t +886 2 2299 3279 Ext. 1259

Quincy CHENG
t +886 2 2299 3279 Ext. 1241