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During 2021 we will continue to support students who need to study remotely due to the ongoing impacts of COVID-19 and travel restrictions. Make sure you check the location code when selecting a unit outline or choosing your units of study in Sydney Student. Find out more about what these codes mean. Both remote and on-campus locations have the same learning activities and assessments, however teaching staff may vary. More information about face-to-face teaching and assessment arrangements for each unit will be provided on Canvas.

Unit of study_

BMET5992: Regulatory Affairs in the Medical Industry

Supply of medical devices, diagnostics and related therapeutic products is regulated in most jurisdictions, with sophisticated and complex regulatory regimes in all large economies. These regulations are applied both to manufacturers and designers and to biomedical engineers undertaking device custom manufacture or maintenance in clinical environments. This UoS will explore the different regulatory frameworks in the 'Global Harmonisation Task Force' group of jurisdictions (US, EU, Canada, Japan, Australia), as well as emerging regulatory practices in Asia and South America. Emphasis will be on the commonality of the underlying technical standards and the importance of sophisticated risk management approaches to compliance.


Academic unit Biomedical Engineering
Unit code BMET5992
Unit name Regulatory Affairs in the Medical Industry
Session, year
Semester 2, 2021
Attendance mode Normal day
Location Remote
Credit points 6

Enrolment rules

AMME4992 OR AMME5992
Assumed knowledge

MECH3921 OR BMET3921 OR AMME5921 OR BMET5921 and 6cp of 1000-level Chemistry and 6cp of Biology units

Available to study abroad and exchange students


Teaching staff and contact details

Coordinator Gregg Jorgen Suaning,
Type Description Weight Due Length
Tutorial quiz hurdle task Quiz 1 - Expectations
Principles of operation - confirming each student understands requirements
0% Week 02 100% required - can be retaken
Outcomes assessed: LO5
Tutorial quiz Quiz 2 - Mid-semester assessment
Assessment of Weeks 1-6
25% Week 07 Approx. 1 hour - details to follow
Outcomes assessed: LO2 LO5
Assignment Regulatory Affairs in the Medical Device Industry
A combined written report and video presentation in a group work format.
25% Week 11 Details to be provided by Week 7
Outcomes assessed: LO1 LO5 LO4 LO3 LO2
Tutorial quiz Quiz 3 - Full Semester Assessment
50% Week 12 Approx. 90 minutes - details to follow
Outcomes assessed: LO2 LO5
hurdle task = hurdle task ?

This unit has four assessment events:

  1. An expectations quiz – this quiz can be completed as many times as required (within the first two weeks) in order to obtain 100%. The score will be used as a multiplier for all remaining components of the unit. For example, obtain 100% (as is the goal), all further marks will be multiplied by 1.0. Similarly, if the student obtains an 80% on this quiz, they should take it again, but if they stop at 80%, all further marks will be multipled by 0.8. This is designed to ensure that all students are aware of the requirements of this unit to avoid miscommunication.
  2. A mid-semester quiz that covers all material up to the week prior.
  3. A end-of-semester quiz that covers all material up to the week prior – including material covered in the first quiz.
  4. A group assignment.

Assessment criteria

The University awards common result grades, set out in the Coursework Policy 2014 (Schedule 1).

As a general guide, a high distinction indicates work of an exceptional standard, a distinction a very high standard, a credit a good standard, and a pass an acceptable standard.

Result name

Mark range


High distinction

85 - 100



75 - 84



65 - 74



50 - 64



0 - 49

When you don’t meet the learning outcomes of the unit to a satisfactory standard.

For more information see

Late submission

In accordance with University policy, these penalties apply when written work is submitted after 11:59pm on the due date:

  • Deduction of 5% of the maximum mark for each calendar day after the due date.
  • After ten calendar days late, a mark of zero will be awarded.

This unit has an exception to the standard University policy or supplementary information has been provided by the unit coordinator. This information is displayed below:

Typically, a 10% penalty per day will applied to the assignment for late submissions up to five days after which a mark of zero (0) will be recorded. For each quiz, a Special Consideration is required in order to facilitate a re-take of the quiz or other assessment event to manage the circumstances.

Special consideration

If you experience short-term circumstances beyond your control, such as illness, injury or misadventure or if you have essential commitments which impact your preparation or performance in an assessment, you may be eligible for special consideration or special arrangements.

Academic integrity

The Current Student website provides information on academic honesty, academic dishonesty, and the resources available to all students.

The University expects students and staff to act ethically and honestly and will treat all allegations of academic dishonesty or plagiarism seriously.

We use similarity detection software to detect potential instances of plagiarism or other forms of academic dishonesty. If such matches indicate evidence of plagiarism or other forms of dishonesty, your teacher is required to report your work for further investigation.

WK Topic Learning activity Learning outcomes
Mid-semester break Mid-semester break (3 hr)  
Week 01 Introduction to instructors, course and assessment. What is a medical device and why regulate – history and an introduction to global regulations. What is the difference between quality and regulatory? Video: The Walking Wounded Tutorial: What went wrong? Common observed problems. (3 hr) LO2
Week 02 Introduction to regulations and the the regulatory submissions around the world - similarities and differences Releationship between Product Development and Regulatory FDA 510(k) and PMA processes. Tutorial: Walk through how to classify and medical device and GSPR templates. QUIZ 1 (due online) (3 hr) LO2
Week 03 Quality Management System (ISO 134845): Design Controls - design and development planning, design input, design review, design verification design validation, design transfer, design changes, design history file. Tutorial: Determining user needs and translating into requirements. (3 hr) LO2 LO5
Week 04 Risk in devices and how to manage them – ISO 14971 and related standards. Tutorial: Hazards and risks (3 hr) LO2 LO5
Week 05 Quality Management System (ISO 134845): Issue Management (NCR, complaints, CAPA, audit, data analysis) with expected problem solving tools. Tutorial: Solving non-conformances to root cause analysis (3 hr) LO2 LO5
Week 06 Documentation Control In the Research Phase Tutorial: Case study - Bionic Eye (3 hr) LO2 LO5
Week 07 QUIZ 2 (3 hr) LO2 LO5
Week 08 The Ventilator Project - Prof Gregg Suaning - High-speed R&D + alternative avenues of meeting regulatory requirements. Tutorial: Lessons learned (3 hr) LO2 LO4 LO5
Week 09 Quality Management System (ISO 134845): Recap and Useful technical standards: Electrical Safety, Biocompatibility, Sterilisation, Packaging Software - software as a medical device, OTS, IT vs QMS, supplier management, manufacturing and process validation Tutorial: Develop a BioC test plan/total test plan for your device (3 hr) LO2 LO5
Week 10 Software - off the shelf, as a medical device & Recap of Semester (3 hr) LO2 LO5
Week 11 Assessment due - Presentations on assignment (3 hr) LO1 LO2 LO3 LO4 LO5
Week 12 Presentations on assignment (continued) & Quiz 3 (3 hr) LO1 LO2 LO3 LO4 LO5
Week 13 OFF SITE: QMS Part 3: Manufacturing Process Controls Medical device careers in Australia (Tour or Virtual Tour of Cochlear Limited) (3 hr) LO2 LO4 LO5

Attendance and class requirements

Attendance is required in all activities. Lectures will be a mix of pre-recorded and ‘live’ streaming in 2021. Live streaming lectures are interactive and accordingly require attendance at the prescribed meeting time. Any lecture recordings made available are for revision only and not a substitute for attendance during the scheduled lecture time.

Study commitment

Typically, there is a minimum expectation of 1.5-2 hours of student effort per week per credit point for units of study offered over a full semester. For a 6 credit point unit, this equates to roughly 120-150 hours of student effort in total.

Learning outcomes are what students know, understand and are able to do on completion of a unit of study. They are aligned with the University’s graduate qualities and are assessed as part of the curriculum.

At the completion of this unit, you should be able to:

  • LO1. define a timeline and meet deadlines for completion of a complex project
  • LO2. understand and adhere to standard medical practices and ethical requirements as part of a product formulation
  • LO3. present findings of a design project in a concise fashion to peers
  • LO4. formulate a biomedical product and adjust to suit specific requirements
  • LO5. demonstrate a broad understanding of international regulatory requirements and the technical and engineering basis of these regulations as they relate to the practice of biomedical engineering in both industrial and clinical environments.

Graduate qualities

The graduate qualities are the qualities and skills that all University of Sydney graduates must demonstrate on successful completion of an award course. As a future Sydney graduate, the set of qualities have been designed to equip you for the contemporary world.

GQ1 Depth of disciplinary expertise

Deep disciplinary expertise is the ability to integrate and rigorously apply knowledge, understanding and skills of a recognised discipline defined by scholarly activity, as well as familiarity with evolving practice of the discipline.

GQ2 Critical thinking and problem solving

Critical thinking and problem solving are the questioning of ideas, evidence and assumptions in order to propose and evaluate hypotheses or alternative arguments before formulating a conclusion or a solution to an identified problem.

GQ3 Oral and written communication

Effective communication, in both oral and written form, is the clear exchange of meaning in a manner that is appropriate to audience and context.

GQ4 Information and digital literacy

Information and digital literacy is the ability to locate, interpret, evaluate, manage, adapt, integrate, create and convey information using appropriate resources, tools and strategies.

GQ5 Inventiveness

Generating novel ideas and solutions.

GQ6 Cultural competence

Cultural Competence is the ability to actively, ethically, respectfully, and successfully engage across and between cultures. In the Australian context, this includes and celebrates Aboriginal and Torres Strait Islander cultures, knowledge systems, and a mature understanding of contemporary issues.

GQ7 Interdisciplinary effectiveness

Interdisciplinary effectiveness is the integration and synthesis of multiple viewpoints and practices, working effectively across disciplinary boundaries.

GQ8 Integrated professional, ethical, and personal identity

An integrated professional, ethical and personal identity is understanding the interaction between one’s personal and professional selves in an ethical context.

GQ9 Influence

Engaging others in a process, idea or vision.

Outcome map

Learning outcomes Graduate qualities
The 2021 version of BMET5992 is updated from previous versions with new UoS coordinator and guest lecturers from industry.

Additional costs

The unit may involve watching a video that is currently available via Netflix. Students may be asked to sign up for one month (or to use promotional offers) to watch one of the videos to be discussed in the unit. Est. cost: $0 to $15

Site visit guidelines

Should the circumstances permit, a site visit to Cochlear will be arranged. As at the time of writing, this appears unlikely in which case a 'virtual tour' will be given with Q&A with Cochlear staff during the session.

Work, health and safety

Social distancing measures will apply to all in-person (if any) components to this unit insofar as a tangible risk of Covid-19 spreading exists.


The University reserves the right to amend units of study or no longer offer certain units, including where there are low enrolment numbers.

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