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An Introduction to Product Development and Quality Management Systems for Health and MedTech Innovation


Oct 02 2023, Monday09:00 AM - 05:30 PM (GMT +8:00) Kuala Lumpur, Singapore


To be informed upon confirmation, To be informed upon confirmation

, Singapore



​This is a 1-day, in-person workshop for those looking to grow their perspectives in encompassing the development of a health and medtech product, de-risking innovation and implementing quality management systems.

Course Description & Learning Outcomes

​​​Topics covered include:​​ ​​​- Overview and Structure of Quality Management System​​ - Product Development Process & Design Controls: Concept Phase and D&P Phase​​ - Product Development Process & Design Controls: D&D and V&V Phases​​ - Requirement Specifications: User Needs ​​ - Risk Management: Hazard Analysis​​ - Hazard Analysis and Risk Controls Exercise[Case study]​​ - Risk Management: Product DFMEA​​ - Requirement Specifications: Design Input​​ - Experiences in early stage projects ​​ - Implementing a QMS post-spin-off​​ By the end of this workshop, you will 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​

Pre-course instructions

Registration close date: 18/09/2023


Date: 02 Oct 2023, Monday
Time: 9:00 AM - 5:30 PM (GMT +8:00) Kuala Lumpur, Singapore
Location: To be informed upon confirmation, To be informed upon confirmation


Course Pricing


Singapore Biodesign