This module aims to provide students with an introduction to and a fundamental understanding of applicable legislation to medical devices in key markets outside EU and US such as Canada, Australia, Japan and emerging markets. The module will provide students with an understanding of the semantics of each classification system and potential regulatory pathways for placing medical devices on the market in global markets. The module will outline and the legal basis for the use of a Notary Public and documents such as Certs of Free Sale, legalised and consularised documentation.

1. Recognise and describe the reason for use of The Hague Convention, Notary Public, Legalisation and Consularisation of documentation

2. Demonstrate an understanding of the basics of applicable legislation in each market
3. Apply appropriate Classification rules fora medical device under each market

4. Demonstrate an understanding of each regulatory system such that one can facilitate regulatory submissions in each market
5. Navigate basic change control principles for each market
6. Demonstrate an understanding of the outline of the STED document and the function of the IMDRF

The aim of this module is to give students an understanding of the importance of sterilisation of medical devices in order to insure there is no risk of microbial contamination following use. The most commonly used sterilisation methods will be discussed, detailing the theory behind the method, advantages and disadvantages and applications of each. Students will also learn about disease causing pathogens, virulence factors and associated risks to public health. This module also introduces the students to biocompatibility testing of medical devices according to the ISO guidelines, highlighting the aims and requirements for a number of assays. An overview of human anatomy, toxicology and pharmacology will also be given to ensure students are aware of the importance and risks associated with poor biocompatibility of medical devices i.e. patient morbidity, immune system response and associated diseases.

1. Explain and predict the risks associated with medical device contamination, routes of contamination, microbial pathogenicity and prevention methods.
2. Summarise sterilisation of medical devices, requirements, application of sterilisation methods to specific materials and sterility testing methods.
3. Evaluate the risks associated with medical device materials from a disease risk and organ biocompatibility view and Demonstrate an understanding of toxicity testing incorporating both target organ and systemic endpoints.

4. Show an ability to interpret biocompatibility testing data generated following testing and to use this to determine a materials level of compatibility.
5. Demonstrate an understanding of the requirements (ISO) to be met and adhered to when ensuring a medical device is both suitably sterilized and biocompatible pre and post sterilisation.

This module aims to provide students with an introduction to current and future knowledge of strategic operations including Industry 4.0, MedTech 4.0, and Smart Operations engineering and management in the context of a GMP environment.

1. DebateManufacturing & Operations Engineering functions and the importance of Operations Engineering Strategy in Product and Service design, Process Technology and Quality Control.

2. Recognise and Define GMP, Manufacturing types and layouts and describe how to balance a line
3. Explain Purchasing, Logistics, and Supply Chain Management concepts as well as Planning and Inventory control in the context of a GMP organization.

4. Explain Industry 4.0 in the context of MedTech 4.0; definition, technologies, various Operations strategies in the context of a GMP organisation.

5. Summarise and explainOperational Excellence; Lean philosophy, Six Sigma;AgileProject Planning in the context of GMP Operations Management.

6. Illustratedata analytics; tools and techniques and calculations to demonstrate understanding and application of the learning outcomes.

This module aims to provide students with an introduction to and a fundamental understanding of how clinical trials are designed to address questions regarding the safety and effectiveness of medical devices. This course addresses the practical issues in the design of medical device trials and protocol development, as well as broader issues related to clinical trial design and interaction between the regulators and sponsors.

1. Outline and evaluatethe reason for current regulations regarding the conduct of clinical trials

2. Recognise and describe theFDA IDE regulations and the ISO14155 requirements

3. Debatethe key roles of individuals involved in clinical research and Describe the key elements of clinical trial design and ICH GCP

4. Evaluatethe key types of clinical trials and Describe the key elements of clinical trial design and ICH GCP

5. Relate Ethical principles and human subject protection and Informed Consent requirements
6. Appraisethe impact of MEDDEV 2.7.1. Rev 4 for Clinical Evaluation in EU and some of the most significant changes

This module introduces the students to labelling and post market requirements for medical devices. It aims to develop the students understanding of what a post market surveillance plan is and how to collect, analyse and respond to data on device safety and performance after market approval. It also aims to provide students with knowledge of the labelling requirements for medical devices.

1. Interpret and explain global statutory reporting requirements including local interpretation and current expectations
2. Appraise post market surveillance requirements and requirement for development of a post market surveillance plan
3. Evaluate the components of a complaint management including assessment, evaluation and response to post market data.
4. Demonstrate knowledge of the requirements for all types of potential field actions including field safety corrective actions, advisory notices and recalls.
5. Evaluate strategies for post market surveillance of medical devices in the US and EU.
6. Communicate an understanding of the EU/US/Global legislation and regulations associated with medical device labelling and global perspectives on UDI, harmonised symbols, structure of IFU, intended use, contraindications, e labelling.

This module will enable students to acquire the research and study skills necessary for successful completion of the Higher Diploma in MedTech Regulatory Affairs and Quality. The module will help students construct technical reports and will develop skills in clear use of language and grammar to ensure compliance. The module will help students develop skills in literature searching, referencing and critiquing peer reviewed literature including data analysis. The module will help students connect the importance of good report writing skills to the workplace and wider society.

1. Demonstrate good writing style in a technical document with correct referencing style
2. Conduct and synthesize an academic literature search relevant to a proposed topic
3. Present the research findings in a critically reflective manner which acknowledges the limitations of the research methods and knowledge produced
4. Critically evaluate a technical document in area such as complianceand clearly demonstrate an awareness of relevance to industry/workplace and societal impact

5. Compare methods for data analysis and the presentation of results and compare different methods when presenting different results