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.
Recommended Prerequisites
Nil
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/Time | Agenda 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 |