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Regulatory Workshop
Co-Organised and Supported by
BES Industry Chapter, SPRING Singapore, & Health Sciences Authority


LATEST UPDATE (28 Sept 2012)
All tickets for the workshops were sold out.  We apologise that we are not able to take in more participants this time.

Should you be interested to be kept on the mailing list for future events, please email us at secretariat@bes.org.sg with your name, organisation and contact details.

 Date:         3-5 October 2012
Time:        0830 – 0900 (Registration)
                   0900 – 1800 (Seminar)
Venue:      Gallery, Level 5, SCAPE, Orchard
Address:   2 Orchard Link Singapore 237978
Please note that there are no complimentary car parking passes for attendees of this workshop.
Trainer: Mr. Sebastiono Pane, TUV Rheinland
  • Framework ISO 13485:2003
    • Design Planning
    • Design Verification
    • Design Validations
    • Design Reviews
    • Technical Documentation
Trainer: Mr. Sebastiono Pane, TUV Rheinland
  • Risk Management Process and Techniques per ISO 14971:2007
  • CE Mark Design Dossier/Technical File per MDD 93/42/EEC
    • Intended Use
    • Classification
    • Essential Requirements
Trainer: Health Sciences Authority (HSA)
  • Overview of Medical Device Regulation in Singapore
  • Risk Classification & Grouping of Medical Devices for Product Registration in Singapore
  • Responsibility of Medical Device Dealers and Good Distribution Practice for Medical Device (GDPMDS) in Singapore
  • Adverse Event and Field Safety Corrective Action Reporting for Medical Device in Singapore

Registration Fees:

3 – 4 Oct 2012 (SOLD OUT)

Medical Device Commercialization: $120 SGD*

(Max Cap: 50 Seats)


5-Oct-2012 (SOLD OUT)

Singapore Regulatory System: $60 SGD*

(Max Cap. 100 Seats)


3 – 5 Oct 2012 (SOLD OUT)

Register for all 3 days for a discounted price of $150 SGD*


*A certificate of completion will be issued to the individual.
*All registration includes seminar notes, daily lunch and tea breaks.


BES (Singapore) is affiliated to the International Federation for Medical and Biological Engineering (IFMBE), and other Asia Pacific Biomedical Engineering Society. Read More

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BES Secretariat: 

Secretariat Contact

Email: secretariat@bes.org.sg
Tel:   +65-63564727
Fax:  +65-63567471
Email: secretariat@bes.org.sg  Please contact relevant ex-co members individually

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