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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

15 Aug 2022 - 7 Oct 2022

 SGD1900*
(before GST)

*Click here for
more details on
SSG funding


Regulation of In Vitro Diagnostic Devices

29 - 30 Nov 2022 15 Aug 2022 - 11 Nov 2022
Post-market vigilance: Regulatory activities for monitoring IVD and SaMD 7 - 8 Feb 2023  TBC

Product development and manufacturing of IVD and SaMD

Design and Development 20 - 21 Feb 2023

1 Dec 2022 - 27 Jan  2023

Validation and Verification 23 - 24 Mar 2023 2 Jan 2023 - 24 Feb 2023
Manufacturing and Quality Management System 25 - 26 Apr 2023 1 Feb 2023 - 24 Mar 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 3 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 3 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 the EC to count towards the requirements for obtaining the GC. The EC is equivalent to 4 Module Credits, or one full module 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 (except for the short course on Post-Market Vigilance, whose approval is pending).

Please click here to view the fees.