Course Description

Conducting Medical Device Clinical Investigations in Singapore

Course Description:

This course outlines the regulations for conducting clinical investigations in the pre- and post-market phases in Singapore.

Note: Regulations may change over time, and a new law is still to be expected to be published. This course will be updated before the publication of the new law.

Watch the Course Trailer:

 

 


Learning Objectives:

Upon successfully completing this course, learners will be able to:

  • Prepare the necessary documents for registering a product in Singapore prior to starting a clinical investigation
  • Integrate the regulatory requirements for clinical investigations into the overall clinical planning process

Who Should Enroll:

Clinical managers, clinical research associates active in Singapore, and regulatory managers are all welcome to participate in this course.


Prerequisite Knowledge/Requirements:

The following series are required:

  • Clinical Project Management Complete 10 Course Suite (IDs 97–106)
  • ISO 14155: In-Depth Review (IDs 61–67)
  • GHTF/IMDRF Regulatory Model for Medical Devices (IDs N169–N173, N182, N187)

Subject Matter Expert:
Danielle Giroud

Duration:
25 min

Release date:
12/05/2012

Related resources:
Yes

Case studies:
No

Peer review:
Yang Tong Foo

Price:
Basic Account: € 76.00
Premium Account: € 57.00

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