Medical Device Technology (MDT CA 1) – Individual Assignment 1

Level 1 (AI) for Planning is the acceptable level of AI that is acceptable for use in this assignment.

Level 1 AI – for PLANNING - to form ideas, structure, and research) on the Artificial Intelligence Assessment Scale Framework is the acceptable.

AI use permitted in this assignment

Any AI process must be declared:

- All AI use must be declared in provided Giffith College Cove Sheet page.

- Learners must add an appendix showing the ideas, structures and recommended research given by an AI*

Acceptable use in this level defined as:

Idea Generation: Using AI to generate suggestion on specific topics that could be included in their assignment. The Learner would then have to research and write the assignment content without AI assistance.

Structure: Asking AI to give an overview or to plan how to discuss the topic of the assignment (e.g. a short bullet points list). The learner would be required to take that list and expand it into a full assignment without further assistance from AI. Research: Asking AI for references to appropriate sources that discuss in topic.

Learners would then be required to read those references. If any of the references are relevant to the assignment it should be then cited in the assignment work.

AI summaries of any source are not permitted.

MDT CA 1 Assignment Overview

Percentage

Mrs. B is a 50-year-old woman who presented to the Accident & Emergency Department following multiple seizure episodes witnessed by her family. She also reports increasing breathlessness and mild headaches.

She has prior history of seizures related to Epilepsy*, which was diagnosed 30 years ago, and recently she was treated for Hypertension* and Chronic Obstructive Pulmonary Disease (COPD)*

You are provided with a clinical case study detailing a patient with primary medical condition and associated comorbidities. Your task is to identify three medical devices—used for diagnosis, monitoring, or treatment—relevant to the patient's condition and/or comorbidities.

Each of the three devices must serve a different purpose

- One device regulated under the In Vitro Diagnostic Regulation (IVDR) for diagnostic purposes, (primary condition or comorbidities)

- One Software as a Medical Device (SaMD) for monitoring, decision support, or related functions. (primary condition or comorbidities)

- One implant device is used directly in the treatment or management of the primary condition or its comorbidities.

You are required to provide a comprehensive analysis of both the pathophysiology of the disease(s) and the technical and clinical functionality of the selected devices. Your assessment must be critical and evaluative, demonstrating an understanding of the technical, clinical, regulatory and ethical aspects of medical devices in healthcare.

Instructions:

Task 1: Case Understanding and Medical Condition / Disease Analysis

Briefly describe the primary medical condition and outline the comorbidities presented in the case.

10%

Task 2: Identification and Justification of Medical Devices.

Identify three medical devices as per the required categories above (IVD, SaMD, and an implant). Justify the selection of each device based on: Specific clinical application and relevance to the patient's pathophysiological state:

- Intended Use

- Indication for use

- Biocompatibility and safety: discuss material compatibility with the human body (where applicable - consider implantation, long-term use, and risk of adverse reactions.)

- Highlight technological strengths and existing limitations (e.g., accuracy, size, cost, maintenance).

30%

Task 3: Device Classification – US

Provide the US classification for each device, including the three-letter product code. Provide a rational for the device classification identified.

26%

Task 4 Device Classification – EU

Provide the EU classification for each device, including the relevant rule (Annex 8). Provide a rational for the device classification identified

26%

Task 5: References

Provide a reference section outlining your sources. Embed your citations in the body of the assignment texts – Use Harvard / Zotero referencing. Sources for the provided Tables, Figures and Pictures must be indicated.

8%

Format of the report.

s Griffith College Cover page.

s The students own cover page which contains Name, Student ID, Date when report is uploaded and title of report.

s Table of contents.

s Acronym table.

s Introduction.

s Name and number paragraphs.

s Conclusion

To support authenticity of your work you need to:

· Summary list of the top10 original reference PDFs, from reputable sources—used in the assignment—must be uploaded alongside the submission. Ensure that all major citations in your assignment are authentic, verifiable, and accessible for review

· Submit a 5-minute Recorded Video Presentation mp4 - this should provide a summary of your research journey and clearly showing all generative AI prompts used during the assignment, explaining their purpose, and defending that only permitted Level 1 AI functions (planning stage, reference suggestions) were used.

Assignment wordcount excluding bibliography: 3,500 -4,500

- Submit softcopy of Assignment to Turnitin Link and a Summary list of the top 10 original reference PDFs on Moodle by - 23:45 on Wednesday 5th of November 2025

- Submit your Recorded Video Presentations mp4 into provided separate Link on Moodle by 23:45 on Wednesday 5th of November 2025

Penalties for the late submissions will apply:

Up to one week late – 10% taken off awarded mark Up to two weeks late – 20% taken off awarded mark More than two weeks late – mark capped at 40%

10%

and physiological effects specific to the chosen condition.

reference to the symptoms and physiological effects.

limited details on symptoms and physiological effects.

reference to symptoms and/or physiological effects.

2.Identification and Justification of 
Medical Devices 30%

Identifies three highly relevant medical devices. Includes an IVD, a SaMD and an implant . Demonstrates deep understanding of device applicability. Demonstrates a clear understanding of differences between indications for use and intended use. Safety of materials and Biocompatibility well explained

Identifies three relevant medical devices. Includes an IVD, a SaMD and implant. Provides an adequate description. Show some understanding of the terms intended use and indications for use. An adequate understanding of safety of materials and biocompatibility.

Identifies medical devices but with minimal relevance or depth. Does not include every device type required. Limited description of device. Does not show a clear understanding of the terms intended use and indications for use. Minimal relevance of safety of materials / biocompatibility

Fails to identify appropriate devices and/or provide description.

Does not show any understanding of the terms intended use and indications for use, safety of materials/ biocompatibility

Correctly identifies the device classification and three letter product code. Provides a limited rational for the device classification identified.

Incorrectly identifies the device classification and three letter product code. Provides a limited rational for the device classification identified.

Fails to correctly identify the device classification and three letter product code. Provides no rational for the device classification identified.

 4. Device Classification– EU 26%

Correctly identifies the device classification and the corresponding rule. Provides a strong rational for the device classification identified, which includes which rules were applicable and not applicable, and a rational why the identified rule was selected.

Correctly identifies the device classification and the corresponding rule.

Provides a limited rational for the device classification identified. Does not identify which rules were applicable and not applicable, and a rational why the identified rule was selected.

 Incorrectly identifies the device classification and the corresponding rule. Provides a limited rational for the device classification identified.

Fails to correctly identifies the device classification and the corresponding rule. Provides no rational for the device classification identified.

5. Referencing (Harvard Style) 8%

References are embedded in the text appropriately, with a comprehensive reference section that includes patents, clinical trials, and other niche sources. Harvard referencing is consistently applied throughout.

References are present and mostly embedded in the text. Harvard referencing is generally followed, though some minor inconsistencies may be present. Limited use of specialized sources.

References are provided but not always embedded in the text. Harvard referencing has noticeable errors, or sources are mostly general rather than specialized.

Few or no references provided.

Referencing is inconsistent or absent, with significant errors in format.