An Introduction to Product Development and Quality Management Systems for Health/MedTech Innovations
About This Course
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
What You'll Learn
This workshop will provide learners with perspectives encompassing the development of a health and medtech product, de-risking innovation and implementing quality management systems.
By the end of the workshop, health & medtech innovators will be able to identify the different milestones to demonstrate medical device readiness from concept to a user-ready final device, apply a framework for risk assessment for early stage projects and apply best practices towards implementing initial quality management systems in early stage projects.
Entry Requirements
Bachelor's Degree or equivalent