96831 Medical Devices: Regulatory and Quality Systems Requirements
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Subject handbook information prior to 2024 is available in the Archives.
Credit points: 6 cp
Result type: Grade and marks
Requisite(s): 96057 GMP for Manufacturing Operations AND 96134 Validation Principles and Practices AND 96059 International GMPs and Quality Assurance AND 96060 Good (Quality Control) Laboratory Practices AND 96069 Contamination Control AND 96062 Good Aseptic Practices and Sterile Products AND 96063 GxP and Quality Auditing Practices AND 96064 Risk Management for Pharmaceutical Operations
There are course requisites for this subject. See access conditions.
Description
This Subject sets out to provide students with an industry focused foundation in Medical Device (including In Vitro Diagnostic Medical Device) regulations, quality management systems and risk management as they apply to the life cycle of the device. The regulatory pathways for the major global markets, including US, EU and Australia, will be studied. An understanding of Quality Management System requirements and how they are implemented under ISO 13485 (1) and FDA 21 CFR Part 820 (2) will be developed. In addition, risk management as it applies to, and is implemented within, the Quality Management System, via ISO 14971 (3), will be covered. These topics will give students foundational knowledge into how a medical device is safely and compliantly designed & developed, manufactured and subsequently marketed in the specified major global markets.
1. ISO 13485:2016 Medical devices — Quality management systems
2. FDA 21 CFR Part 820 - Quality System Regulation
3. ISO 14971:2019 Medical Devices - Application of Risk Management To Medical Devices
Subject learning objectives (SLOs)
| 123. | Compare and contrast the different regulatory structures in the larger markets (USA, EU & Australia). |
|---|---|
| 124. | Implement and evaluate Quality Management Systems for medical devices. |
| 125. | Apply regulatory requirements to the development and manufacture of medical devices. |
| 126. | Evaluate compliance to regulatory requirements and make recommendations for improvement. |
| 127. | Apply ISO 14971: Medical devices to the risk management of medical devices. |
| 128. | Devise a risk assessment for a medical device including risk analysis, risk evaluation and implementation of appropriate risk controls. |
Course intended learning outcomes (CILOs)
The learning outcomes for this subject are as follows:
- Reflect on the knowledge, skills and attributes required for the evaluation and integration of emerging evidence into practice, promoting the growth of personal and professional learning, and the education of others. (01.09)
- Demonstrate accurate and comprehensive knowledge of risk management practices and models, and implement and evaluate them in a range of contexts. (02.01)
- Test, audit and validate pharmaceuticals manufacturing and distribution processes using appropriate methodologies. (02.02)
- Design, implement and evaluate control systems for pharmaceuticals manufacturing. (02.03)
- Demonstrate ethically and legally accountable approaches to pharmaceuticals manufacturing and control. (02.04)
- Analyse and synthesise knowledge of relevant concepts and theory, and apply skills of scientific research and reasoning to support Good Manufacturing Practice. (02.05)
- Produce accurate technical documentation, and communicate effectively and accurately with clients and stakeholders in written or spoken language appropriate to their needs. (02.06)
- Contribute as leader and collaborator in the assurance of Good Manufacturing Practice. (02.08)
- Demonstrate knowledge of Good Manufacturing Practice in local, national and global contexts. (03.11)
Contribution to the development of graduate attributes
This Subject combines the knowledge, skills and attributes acquired throughout the Master of Good Manufacturing Practice (MGMP), and applies them to the medical device industry at a global level.
This Subject contributes towards developing the following Graduate Attributes:
Lifelong learning:
Graduates of the Master of GMP are lifelong learners, committed to and capable of reflection and inquiry in their quest for personal development and excellence in professional practice.
Professional capacity:
Graduates of the Master of GMP are industry-focused, ethical practitioners with the understanding and proficiency to be leaders in their profession, capable of effectively analysing and implementing solutions in a global context under international regulatory guidelines.
Global citizenship:
Graduates of the Master of GMP contribute to society, resolving to undertake those actions and responsibilities that will enhance their role in local, national and global communities.
Teaching and learning strategies
On campus (standard) mode: This subject will be delivered on the City campus and requires attendance for three hours of face-to-face contact per week, as well as approximately 1-3 hours of personal study pre-work before each class. However, should restrictions related to COVID-19 require it, classes for this subject will be conducted online. The format and content of online classes (should they be required) will be equivalent to face to face on-campus classes and the same attendance requirements apply.
Online (distance) mode: This subject is delivered online via Canvas. Students are required to contribute to weekly discussions as well as participate in occasional online meetings via zoom when required. Students should dedicate approximately 3-6 hours of time to this subject per week. Students will learn in this Subject through online content comprising videos, set reading, directed research, activities, online discussions and self-check quizzes. This independent learning will be supported by group learning experiences, in which ideas and concepts can be tested and refined
Strategy 1: Student directed learning: Students read articles and use online resources, such as online course material, videos, directed research, activities, self-check quizzes and case studies, provided via Canvas. This learning prepares students for their participation in activities that may include facilitated discussion of fundamental concepts drawn from course materials and solutions to industry case studies, assessable quizzes or activities as well as collaborative and interactive learning experiences.
Strategy 2: Collaborative and interactive learning experiences: Provide the students with the opportunity to engage with Peers and Academics to discuss and clarify concepts for a deeper understanding of online course materials.
On campus students - engage in a weekly 3 hour workshop. Each workshop aims to apply online course materials to real life pharmaceutical industry scenarios through discussions and problem solving in collaboration with fellow students.
Online students – engage in weekly discussion forums. Each online discussion aims to apply course material in real life pharmaceutical industry scenarios and collaboration with fellow students is required by posting and responding to other students posts in the discussion forum. Students participate in the online discussions by writing their comments in the Canvas platform in their own time and also read and respond to posts from peers. Each discussion has an end time designated by which students must have contributed.
Strategy 3: Early and consistent feedback: Early feedback is provided prior to the census date.
On campus students – receive feedback in workshops or via the Canvas platform for activities. Feedback regarding the quizzes is provided following each quiz, via provision of answers and/or in-class review. The collaborative learning approach utilised in class will enable ongoing feedback to be provided in class, as areas of learning need are identified through class discussions.
Online students – receive feedback during ‘open office’ hours and discussion forums. Feedback regarding the self-check quizzes is provided via Canvas immediately upon submission of each quiz. The collaborative learning approach will enable ongoing feedback to be provided to students, via teacher responses to posts, as areas of learning need are identified through online discussions.
Strategy 4: Group work: students work in groups during collaborative and interactive experiences. Students will need to coordinate group work, fostering negotiation, team building and teamwork skills. Students will need to demonstrate the ability to respond respectfully and constructively to their peers, fostering communication, constructive criticism and and respect for diverse ways of working.
Strategy 5: Students are encouraged to critically reflect on their learning throughout the subject to identify areas where they may improve their performance and develop lifelong learning skills.
Content (topics)
The subject will commence with an overview of quality management systems and regulatory environments applicable to medical devices in the major markets covering the benefits of the systems and alignment across jurisdictions and industry sectors. The application of medical device regulation to the design, development, manufacturing and provision of medical devices will be covered in detail including Management Responsibility, Resource Management and Product Realisation and leading into continuous improvement practices. Risk management will be studied, introducing ISO 14971 and looking at its application to various scenarios.
Assessment
Assessment task 1: On-going Graded Assessment
| Intent: | Throughout the semester you will have the opportunity to check your understanding of the course content via graded assessments through the Canvas platform. |
|---|---|
| Objective(s): | This task is aligned with the following subject learning objectives: 123, 124, 125, 126 and 127 This task is aligned with the following course learning outcomes: 01.09, 02.01, 02.02, 02.03, 02.04, 02.05, 02.08 and 03.11 |
| Groupwork: | Individual |
| Weight: | 15% |
| Criteria: | Provided via Canvas |
Assessment task 2: Registration and Review of Medical Devices
| Intent: | Successful registration of a new medical device relies on an understanding of how regulatory systems operate in different jurisdictions, and successful manufacture of a medical device relies on an effective QMS. In this scenario based assessment students demonstrate their understanding of these elements of medical device regulation by applying them to a specific medical device. |
|---|---|
| Objective(s): | This task is aligned with the following subject learning objectives: 123, 124, 125 and 126 This task is aligned with the following course learning outcomes: 01.09, 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.08 and 03.11 |
| Type: | Report |
| Groupwork: | Individual |
| Weight: | 45% |
| Length: | 2000-3000 words |
| Criteria: | Published in the Assessments section of Canvas for this subject. |
Assessment task 3: Risk Management in Medical Devices
| Intent: | Risk management is an ongoing process once the device is on the market. This assessment enables you to demonstrate your ability to assess and mitigate risk in the context of an authentic scenario. |
|---|---|
| Objective(s): | This task is aligned with the following subject learning objectives: 127 and 128 This task is aligned with the following course learning outcomes: 01.09, 02.01, 02.02, 02.03, 02.04, 02.05, 02.06, 02.08 and 03.11 |
| Type: | Presentation |
| Groupwork: | Group, individually assessed |
| Weight: | 40% |
| Length: | Maximum 20 minute presentation and maximum 10 minutes question time |
| Criteria: | Published in the Assessments section of Canvas for this subject. Your group grade will be individually moderated by a SPARK evaluation. |
Minimum requirements
On Campus Mode
In order to pass this Subject, a minimum grade of 50% must be achieved.
Students are required to attend a minimum of 85% of classes, and submit all assessment tasks
Online Mode
In order to pass this Subject, a minimum grade of 50% must be achieved and students must submit all assessment tasks.
Required texts
Provided via the subject Canvas site:
Coursework Assessments Procedures
Graduate School of Health Policy, Guidelines and Procedures (login required)
Additional readings will be provided via Canvas.
Recommended texts
ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 14971:2019 Medical devices — Application of risk management to medical devices