Outline

Overview

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.

Unit details and rules

Unit code	BMET5992
Academic unit	Biomedical Engineering
Credit points	6
Prohibitions ?	AMME4992 OR AMME5992
Prerequisites ?	None
Corequisites ?	None
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	Yes

Teaching staff

Coordinator	Gurvinder Singh, gurvinder.singh@sydney.edu.au
Lecturer(s)	Gurvinder Singh, gurvinder.singh@sydney.edu.au
Lecturer(s)	Steven Kennedy, steven.kennedy@sydney.edu.au

Type	Description	Weight	Due	Length
Tutorial quiz	Weekly Quiz Weekly quiz based on the lecture starting from week 2 to week 13.	40%	Week 02	Approx. 30 min
Outcomes assessed:
Assignment	Regulatory Affairs in the Medical Device Industry Group presentation	20%	Week 08 Due date: 22 Sep 2023 at 16:00	10 min+ 3 min Q&A
Outcomes assessed:
Assignment	Group written Assignment Assessment based on the group report	40%	Week 12 Due date: 27 Oct 2023 at 23:59	Written report
Outcomes assessed:
= group assignment ?

Assessment summary

This unit has three assessment events:

Weekly quiz that covers each week delivered lecture content
A group presentation
A group written assignment.

Assessment criteria

The University awards common result grades, set out in the Coursework Policy 2021 (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	Description
High distinction	85 - 100	To be awarded to students who, in their performance in assessment tasks, demonstrate the learning outcomes for the unit at an exceptional standard as defined by grade descriptors or exemplars established by the faculty.
Distinction	75 - 84	To be awarded to students who, in their performance in assessment tasks, demonstrate the learning outcomes for the unit at a very high standard as defined by grade descriptors or exemplars established by the faculty.
Credit	65 - 74	To be awarded to students who, in their performance in assessment tasks, demonstrate the learning outcomes for the unit at a good standard as defined by grade descriptors or exemplars established by the faculty.
Pass	50 - 64	To be awarded to students who, in their performance in assessment tasks, demonstrate the learning outcomes for the unit at an acceptable standard as defined by grade descriptors or exemplars established by the faculty.
Fail	0 - 49	To be awarded to students who, in their performance in assessment tasks, fail to demonstrate the learning outcomes for the unit at an acceptable standard established by the faculty. This grade, with corresponding mark, should also be used in cases where a student fails to achieve a mandated standard in a compulsory assessment, thereby failing to demonstrate the learning outcomes to a satisfactory standard. In such cases the student will receive the mark awarded by the faculty up to a maximum of 49.

For more information see sydney.edu.au/students/guide-to-grades.

For more information see guide to grades.

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:

The Assessment Procedures 2011 provide that any written work submitted after 11:59pm on the due date will be penalised by 5% of the maximum awardable mark for each calendar day after the due date. If the assessment is submitted more than ten calendar days late, a mark of zero will be awarded. 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.

Academic integrity

The Current Student website provides information on academic integrity 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 integrity breaches seriously.

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

You may only use artificial intelligence and writing assistance tools in assessment tasks if you are permitted to by your unit coordinator, and if you do use them, you must also acknowledge this in your work, either in a footnote or an acknowledgement section.

Studiosity is permitted for postgraduate units unless otherwise indicated by the unit coordinator. The use of this service must be acknowledged in your submission.

Learning support

Simple extensions

If you encounter a problem submitting your work on time, you may be able to apply for an extension of five calendar days through a simple extension.  The application process will be different depending on the type of assessment and extensions cannot be granted for some assessment types like exams.

Special consideration

If exceptional circumstances mean you can’t complete an assessment, you need consideration for a longer period of time, or if you have essential commitments which impact your performance in an assessment, you may be eligible for special consideration or special arrangements.

Special consideration applications will not be affected by a simple extension application.

Using AI responsibly

Co-created with students, AI in Education includes lots of helpful examples of how students use generative AI tools to support their learning. It explains how generative AI works, the different tools available and how to use them responsibly and productively.

Weekly schedule

WK	Topic	Learning activity
Week 01	Introduction to medical device regulations. Definitions of medical devices, reasons for regulating medical devices, global frameworks for regulations, Quality and Regulatory departments in medical device companies.	Lecture and tutorial (3 hr)
Week 02	European and Australian medical device regulations. History, classification systems, approval pathways, post-market obligations. FDA 510(k) and PMA processes.	Lecture and tutorial (3 hr)
Week 03	US and Chinese medical device regulations. History, classification systems, approval pathways, post-market obligations.	Lecture and tutorial (3 hr)
Week 04	ISO 13485. Purpose of quality management systems, comparison with ISO9001 and 21 CFR 820, key elements of ISO13485.	Lecture and tutorial (3 hr)
Week 05	ISO 13485 continued. Management responsibility, resource management, product realisation, measurement, analysis and improvement.	Lecture and tutorial (3 hr)
Week 06	ISO 14971. Framework for risk analysis, safety by design, risk control measures, ongoing review and monitoring.	Lecture and tutorial (3 hr)
Week 07	ISO 10993. Set of biocompatibility standards.	Lecture and tutorial (3 hr)
Week 08	Assignment presentations.	Lecture and tutorial (3 hr)
Week 09	Labelling and Instructions for Use. Why labelling is so important, applicable standards, specific country requirements, Unique Device Identifier.	Lecture and tutorial (3 hr)
Week 10	Recalls. Recall classifications, reasons for recalls, case studies.	Lecture and tutorial (3 hr)
Week 11	Software as a medical device. Challenges for software devices, classification, cyber security, artificial intelligence.	Lecture and tutorial (3 hr)
Week 12	Guest speakers from medical device industry.	Presentation (3 hr)
Week 13	Cochlear site tour	Lecture and tutorial (3 hr)

Attendance and class requirements

Students are expected to attend and actively engage in all timetabled activities of a unit of study. Students are required to be in attendance at the correct time and place of any formal or informal examinations and scheduled assessments. Non-attendance on any grounds insufficient to claim special consideration will result in the forfeiture of marks associated with the assessment.

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

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.

Outcomes
Graduate qualities

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

LO1. define a timeline and meet deadlines for the 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
Learning outcomes

Responding to student feedback

This section outlines changes made to this unit following staff and student reviews.

The 2022 version of BMET5992 is updated from previous versions with new UoS coordinator and guest lecturers from industry.

Additional information

Library access to standards

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.

Disclaimer

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

To help you understand common terms that we use at the University, we offer an online glossary.

Current students

Overview

Overview

Unit details and rules

Teaching staff

Assessment

Assessment

Assessment summary

Assessment criteria

Late submission

Academic integrity

Learning support

Learning support

Simple extensions

Special consideration

Using AI responsibly

Weekly schedule

Weekly schedule

Attendance and class requirements

Study commitment

Learning outcomes

Learning outcomes

Graduate qualities

Outcome map

Responding to student feedback

Responding to student feedback

Additional information

Additional information

Site visit guidelines

Disclaimer

On this page

Useful links

Media

Student links

About us

Connect

Current students

BMET5992: Regulatory Affairs in the Medical Industry

Semester 2, 2023 [Normal day] - Camperdown/Darlington, Sydney

Overview

Overview

Unit details and rules

Teaching staff

Assessment

Assessment

Assessment summary

Assessment criteria

Late submission

Academic integrity

Learning support

Learning support

Simple extensions

Special consideration

Using AI responsibly

Weekly schedule

Weekly schedule

Attendance and class requirements

Study commitment

Learning outcomes

Learning outcomes

Graduate qualities

Outcome map

Responding to student feedback

Responding to student feedback

Additional information

Additional information

Site visit guidelines

Disclaimer

On this page

Useful links

Media

Student links

About us

Connect