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.

 

3-Oct-2012:

Trainer: Mr. Sebastiono Pane, TUV Rheinland

• Framework ISO 13485:2003
  • Design Planning
  • Design Verification
  • Design Validations
  • Design Reviews
  • Technical Documentation

 

4-Oct-2012:

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

 

5-Oct-2012:

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)

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5-Oct-2012 (SOLD OUT)

Singapore Regulatory System: $60 SGD*

(Max Cap. 100 Seats)

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3 – 5 Oct 2012 (SOLD OUT)

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

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*A certificate of completion will be issued to the individual.

*All registration includes seminar notes, daily lunch and tea breaks.