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AMME4992: Regulatory Affairs in the Medical Industry (2016 - Semester 2)

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Unit: AMME4992: Regulatory Affairs in the Medical Industry (6 CP)
Mode: Normal-Day
On Offer: Yes
Level: Senior Advanced
Faculty/School: School of Aerospace, Mechanical & Mechatronic Engineering
Unit Coordinator/s: Professor Ruys, Andrew
Session options: Semester 2
Versions for this Unit:
Campus: Camperdown/Darlington
Pre-Requisites: MECH2901 AND MECH3921.
Brief Handbook Description: 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.
Assumed Knowledge: 6 cp junior chemistry and 6 cp biology
Additional Notes: Biomedical Engineering Elective Unit of Study.
Timetable: AMME4992 Timetable
Time Commitment:
# Activity Name Hours per Week Sessions per Week Weeks per Semester
1 Lecture 3.00 1 13
2 Independent Study 5.00
T&L Activities: Independent Study: Follow up research and assignment work.

Attributes listed here represent the key course goals (see Course Map tab) designated for this unit. The list below describes how these attributes are developed through practice in the unit. See Learning Outcomes and Assessment tabs for details of how these attributes are assessed.

Attribute Development Method Attribute Developed
• Ethical, social, and professional understanding. This will be developed through the lecture material.
• Personal and intellectual autonomy. This will be developed through private study associated with the lecture material.
• Research and enquiry. This will be developed through the group project activities.
• Information literacy. This will be developed through the group project activities.
• Communication. This will be developed through the scheduled seminars.
Professional Conduct (Level 3)

For explanation of attributes and levels see Engineering & IT Graduate Outcomes Table.

Learning outcomes are the key abilities and knowledge that will be assessed in this unit. They are listed according to the course goal supported by each. See Assessment Tab for details how each outcome is assessed.

Communication (Level 3)
1. 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.
Assessment Methods:
# Name Group Weight Due Week Outcomes
1 Assignment No 50.00 Week 13 (Tuesday, 2 pm) 1,
2 Team Project Report Yes 30.00 Week 12 (Tuesday, 2 pm) 1,
3 Team Seminar Yes 20.00 Week 12 (Tuesday, 2 pm) 1,
Assessment Description: Assignment: Assignment: Regulatory strategy report on nominated product to include design and production risks and validations, and premarket submission requirements for global product launch for a nominated medical device or diagnostic.

Assessment will be based on final project report and seminar presentation. There is no examination.

The assignment report is due in week 12.
Grade Type Description
Standards Based Assessment Final grades in this unit are awarded at levels of HD for High Distinction, DI (previously D) for Distinction, CR for Credit, PS (previously P) for Pass and FA (previously F) for Fail as defined by University of Sydney Assessment Policy. Details of the Assessment Policy are available on the Policies website at . Standards for grades in individual assessment tasks and the summative method for obtaining a final mark in the unit will be set out in a marking guide supplied by the unit coordinator.
Policies & Procedures: See the policies page of the faculty website at for information regarding university policies and local provisions and procedures within the Faculty of Engineering and Information Technologies.
Note on Resources: Lecture notes will be supplied in class.

Note that the "Weeks" referred to in this Schedule are those of the official university semester calendar

Week Description
Week 1 Why regulate – some history and an introduction to global regulations. Introduction to course projects.
Week 2 The regulatory submission. Classification, Technical Files and Essential Principles/Requirements. FDA 510(k) and PMA processes.
Week 3 Guest Lecturer – TGA – realities of regulatory practice
Week 4 Risk management – ISO 14971 and related standards. Class case studies and exercises
Week 5 Design Controls. ISO 13485 and 21 CFR 820.30 requirements. Role of Industrial design.
Week 6 Technical standards. Electrical safety, biological testing, sterilization
Week 7 ISO 13485 Manufacturing controls. Documentation requirements. Process validation – guest lecturer from industry. Review of progress – student projects.
Week 8 Regulation of Emerging Technologies. Cellular therapies, Tissue engineered products, companion diagnostics.
Week 9 WEEE, RoHS, REACH and all that other stuff. Regulations on environmental compliance, genetic testing, hazardous materials and more.
Week 10 Postmarket. Reimbursement, market acceptance, continuing compliance: adverse events, registries, recalls. – Case studies.
Week 11 Review and summary
Week 12 Student project presentations.
Assessment Due: Team Project Report
Assessment Due: Team Seminar
Week 13 Student project presentations.
Assessment Due: Assignment
Exam Period No exam. All assessment by assignment and seminar.

Course Relations

The following is a list of courses which have added this Unit to their structure.

Course Year(s) Offered
Mechanical (Biomedical) (till 2014) 2010, 2011, 2012
Mechanical Engineering (Biomedical) / Medical Science 2010, 2011, 2012
Biomedical Engineering / Law 2013, 2014
Biomedical Engineering / Arts 2013, 2014
Biomedical Engineering / Commerce 2013, 2014
Biomedical Engineering / Medical Science 2013, 2014
Biomedical Engineering / Project Management 2013, 2014
Biomedical Engineering / Science 2013, 2014
Biomedical - Chemical and Biomolecular Major 2013, 2014, 2015
Biomedical - Electrical Major 2013, 2014
Biomedical - Information Technology Major 2013, 2014, 2015
Biomedical - Mechanical Major 2013, 2014, 2015
Biomedical - Mechatronics Major 2013, 2014, 2015
Electrical (Bioelectronics) (till 2012) 2011, 2012
Electrical Engineering (Bioelectronics) / Arts 2011, 2012
Electrical Engineering (Bioelectronics) / Science 2011, 2012
Biomedical Mid-Year 2016
Biomedical / Arts 2015, 2016
Biomedical / Commerce 2015, 2016
Biomedical / Medical Science 2015, 2016
Biomedical / Music Studies 2016
Biomedical / Project Management 2015, 2016
Biomedical /Science 2015, 2016
Biomedical - Electrical Major 2015
Biomedical / Law 2015, 2016
Mechanical Engineering (Biomedical) / Arts 2011, 2012
Mechanical Engineering (Biomedical) / Commerce 2012
Mechanical Engineering (Biomedical) / Project Management 2012
Mechanical Engineering (Biomedical) / Science 2011, 2012
Mechanical Engineering (Biomedical) / Law 2012
Biomedical/Science (Medical Science Stream) 2018, 2019

Course Goals

This unit contributes to the achievement of the following course goals:

Attribute Practiced Assessed
Project and Team Skills (Level 3) No 0%
Communication (Level 3) No 100%
Professional Conduct (Level 3) Yes 0%

These goals are selected from Engineering & IT Graduate Outcomes Table which defines overall goals for courses where this unit is primarily offered. See Engineering & IT Graduate Outcomes Table for details of the attributes and levels to be developed in the course as a whole. Percentage figures alongside each course goal provide a rough indication of their relative weighting in assessment for this unit. Note that not all goals are necessarily part of assessment. Some may be more about practice activity. See Learning outcomes for details of what is assessed in relation to each goal and Assessment for details of how the outcome is assessed. See Attributes for details of practice provided for each goal.