Overview
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
Recommended Prerequisites
Nil
Pre-course instructions
Registration close date: 18/09/2023
Schedule
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
Pricing
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