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

 

Mar 22 2024, Friday09:00 AM - 05:30 PM (GMT +8:00) Kuala Lumpur, Singapore

 

Physical, To be informed upon confirmation

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Overview

​This is a 1-day 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

​​​​An Introduction to Product Development and Quality Management Systems for Health and MedTech is jointly presented by SGInnovate and Singapore Biodesign​​​ ​​​This workshop aims to equip healthcare innovators, including healthcare professionals, researchers, engineers and budding healthcare entrepreneurs with perspectives encompassing the development of a health and medtech product, de-risking innovation and implementing quality management systems​​ ​​​​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: 19/1/2024

Schedule

Date: 22 Mar 2024, Friday
Time: 9:00 AM - 5:30 PM (GMT +8:00) Kuala Lumpur, Singapore
Location: Physical, To be informed upon confirmation

Agenda

Day/TimeAgenda Activity/Description
Day 1 | 9AM-530PM- Overview & 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​​ - ​​​User Needs - Hazard Analysis​​ ​​​- Hazard Analysis & Risk Controls Exercise[Case study]​​ - Product DFMEA​​ - Design Input - Experiences in early stage projects - Implement QMS post spin-off

Pricing

Course Pricing
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