
CERTIFICATE
OF COMPLETION
This is to certify that
Lucas Tay Hao Yang
has successfully completed the course requirements for the course
An Introduction to Product Development and Quality Management Systems for Health and MedTech Innovations
26/03/2025
Professor Silke VOGEL, PhD
Senior Associate Dean, Graduate Studies
Deputy Director, Centre of Regulatory Excellence
Head, Centre for Lifelong Learning |Duke-NUS Medical School Singapore
Serial No.: 138268204

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Dr Lee Phin Peng
Acting Programme Director
Singapore Biodesign
An Introduction to Product Development and Quality Management Systems for Health/MedTech Innovations
Lucas Tay Hao Yang
By the end of this module, you should be able to
-Analyse and articulate key design requirement specifications
-Assess technology to design and develop functional proof-of-concept prototypes, and determine what tests are required to de-risk the project
-Respond and manage potential product development risks, develop a mitigation plan and manage risks
-Collaborates with different internal stakeholders (e.g., engineers and scientists) to define product requirements, develop prototype and validate results
-Understands the required regulatory and quality requirements, i.e., guidance documents, standards for different kinds of innovation projects; Able to design and carry out necessary tests and documentation.
-Apply basic quality management standards to ensure adherence to ISO standards in the early product development stages
Issued on
March 27, 2025
Expires on
Does not expire