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Executive Certificates (Medical Devices)

CALENDAR 2022-2023

 
Executive Certificate  Course  Date  Registration   Fees

Regulatory requirements of IVD and SaMD

Regulation of Software as a Medical Device

25 - 26 Oct 2022

 Registration Closed

 SGD1900* per course
(before GST)

*Click here for
more details on
SSG funding


Regulation of In Vitro Diagnostic Devices

29 - 30 Nov 2022  Registration Closed
Post-market vigilance: Regulatory activities for monitoring IVD and SaMD 7 - 8 Feb 2023  Registration Closed

Product development and manufacturing of IVD and SaMD

Design and Development 20 - 21 Feb 2023

 Registration Closed

Validation and Verification 23 - 24 Mar 2023  Registration Closed
Manufacturing and Quality Management System 25 - 26 Apr 2023  1 Feb 2023 - 14 April 2023
   
  

Programme structure and courses

 
As evidenced during the current COVID-19 pandemic, the rapid development of reliable in-vitro diagnostic kits is an essential component for the effective management of urgent public health needs. The shift towards digital health and precision medicine further highlights the emphasis to support innovation of healthcare applications and diagnostic kits. In supporting the rapid growth of In-Vitro Diagnostic Devices (IVD) and Software as Medical Devices (SaMD), as well as facilitating the access of these important health products to consumers, CoRE presents two Executive Certificates (EC) to cater to professionals in health product development and research, regulation and healthcare services. Each EC focuses on the two key components in enhancing the entry of these innovations  - product development and regulatory requirements. 

 

Each EC consists of three short courses. The short courses are 2-day workshops, containing essential topics for the working professionals, while maintaining a comprehensive scope. The short courses for each EC are typically conducted within a 3-6 months period, allowing the candidate to finish the learning journey efficiently.
 

Candidates who complete the three short courses (with minimum Pass grades) will obtain the corresponding Executive Certificate. For professionals who are not pursuing the EC, they can choose to attend the specific short course according to their need, without the obligation to finish all three short courses. However, in the event of an overwhelming enrolment, priority may be given to candidates who are pursuing the EC.
 

Candidates who are pursuing the CoRE’s Graduate Certificate in Health Products Regulation (GC) can have the option of using one EC to count towards the requirements for obtaining the GC. One EC is equivalent to 4 Units, or one full course under the GC programme. 

REQUIREMENTS AND FEES

 
Applicants must have an undergraduate Bachelor’s degree or its equivalent in relevant discipline. Relevant work experience (i.e., in the fields of health product development, research, regulatory and healthcare) at the time of matriculation into Duke-NUS Medical School is desirable. Applicants from non-English speaking countries will be required to present documentary evidence of their competence in written and spoken English (TOEFL or ILS).

The short courses under the two ECs are supported by SSG.

Please click here to view the fees.

Please prepare the following documents when submiting your application:

  • NRIC/Passport
  • Highest Academic certificates
  • Highest Academic transcripts
  • Latest CV (with current job duties)