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.
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.
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*All costs presented here are inclusive of 8% GST
Course Objectives
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
For enquiries please reach out to [email protected] or [email protected].
Agenda
By the end of this 1-day workshop, learn to identify the different milestones to demonstrate medical device readiness, from concept to a user-ready final device. Dive into frameworks for risk assessment for early-stage projects and apply best practices towards implementing initial quality management systems in early-stage projects.
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
