QLTY07037 2019 Medical Device Manufacturing

Demonstrate a knowledge and understanding of the medical device industry, the principal companies involved and the main product types being manufactured.   

Explain the various principles and practices involved in the control and regulation of the medical device industry

Describe the theory, practice and practical applications of polymer-based medical devices.   

Describe the theory, practice and practical applications of medical devices manufactured from a variety of other materials such as metals, natural materials, composites.      

Compare and contrast the principal steps involved in the manufacturing of a range of different medical device products.

Explain the various principles and practices involved in the validation of medical device processes

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Theory Syllabus:

1.0       Introduction to Medical Device Manufacturing. 

1.1       Global Medical Device Manufacturing and Emerging Trends. 

1.2       The Medical Technologies Industry in Ireland. 

1.3       The Future direction for the Medical Device Industry. 

2.0       Medical Device Classification and Certification. 

2.1       A review of the European Medical Device Directives. 

2.2       The classification of Medical Devices. 

2.3       The CE marking process for Medical Devices. 

2.4       FDA regulation of Medical Devices.

3.0       Polymer-based Medical Devices. 

3.1       A review of the main polymers and their applications. 

3.2       A study of polymer processing - thermoplastics vs. thermosetting polymers.

3.3       Injection molding, Blow Moulding, compression molding and polymer extrusion. 

3.4       Joining and bonding of plastics. 

4.0          Metals and other materials for Medical Device Products. 

4.1          The processing of metals - casting, forging, welding, machining, plasma spraying. 

4.2          Metal surface finishing techniques. 

4.3          Other materials for Medical Devices - ceramics and glasses, natural materials and composites. 

5.0          Typical Medical Devices and their Manufacturing. 

5.1          A study of the manufacture of coronary artery stents including drug-eluting stents. 

5.2          A study of the manufacture of heart valves. 

5.3          A study of the manufacture of catheters

5.3          A study of the manufacture of pacemakers and defibrillators. 

5.4          A study of the manufacture of prosthetics

5.5          The study of a variety of other Medical Devices including In Vitro Diagnostics and  biosensors.

6.0           Validation of Medical Devices

6.1           Introduction to Validation and Validation Principles

6.2           Process Validation of a medical device manufacturing process 

6.3           Test Method Validation

7.0           Other Support services for the manufacture of medical devices

7.1           Medical Device Sterilisation

7.2           Product Packaging and Labelling

INDICATIVE PRACTICAL/ PROJECT

The practical element associated with this module will be based on a project assignment. It will involve the detailed review and study of an aspect of medical device manufacturing, and the generation of a project report. Individuals will also have to deliver a team-based presentation of the main findings to the overall class. The project progess will be reviewed on an ongoing basis by the lecturer who will provide tutorials on project management and coordination, teamwork, report writing and project presentation techniques.