Available in 2022
Course code



10 units


3000 level

Course handbook


On completion of this course, students have a broad appreciation of the factors associated with the critical area of approval of medical devices prior to broad scale release. Students develop skills in product development both in terms of potential physical objects and the associated quality systems needed to ensure regulatory approvals. The course highlights how the regulated environment impacts the design, testing and delivery of medical devices. Invited speakers who currently work in the industry will present case studies on data collation and documentation methods necessary for the medical engineering field.

Availability2022 Course Timetables


  • Semester 1 - 2022

Learning outcomes

On successful completion of the course students will be able to:

1. Describe the principles of operation of the major medical device regulatory systems in a global context

2. Apply key regulatory concepts to a medical device development process, including intended use and risk class

3. Operate within a quality management system to maintain compliance to key design, manufacturing and post-market requirements

4. Produce an industry relevant risk assessment of a medical device

5. Determine relevant standards applying to medical device development

6. Create the technical documentation required for medical device market authorisation


  • Medical engineering regulation: history and rationale
  • Best practice processes for design and manufacturing to meet regulatory requirements in medical engineering
  • General standards in medical engineering
  • Benefit-risk considerations
  • Specific safety systems and standards
  • Software development requirements in medical systems
  • Quality systems in medical engineering
  • Documentation for device approvals: requirements and obligations
  • Post-market responsibilities

Assessment items

Quiz: Quizzes x 2

Written Assignment: Assignment 1

Written Assignment: Assignment 2

Formal Examination: Examination

Contact hours



Face to Face On Campus 2 hour(s) per Week for Full Term starting in week 1


Face to Face On Campus 2 hour(s) per Week for Full Term starting in week 2

The University of Newcastle acknowledges the traditional custodians of the lands within our footprint areas: Awabakal, Darkinjung, Biripai, Worimi, Wonnarua, and Eora Nations. We also pay respect to the wisdom of our Elders past and present.