Module Specifications.
Current Academic Year 2024 - 2025
All Module information is indicative, and this portal is an interim interface pending the full upgrade of Coursebuilder and subsequent integration to the new DCU Student Information System (DCU Key).
As such, this is a point in time view of data which will be refreshed periodically. Some fields/data may not yet be available pending the completion of the full Coursebuilder upgrade and integration project. We will post status updates as they become available. Thank you for your patience and understanding.
Date posted: September 2024
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Repeat examination Repeat examination. |
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Description To further the student's understanding of product design and development and explore in detail the key elements and constraints to be considered in medical device design. To familarise the students with the primary regulatory issues affecting medical device design and production. To engender in the student an awareness and appreciation of the nature and critical importance of regulatory compliance to product development in the medical device industry. | |||||||||||||||||||||||||||||||||||||||||||
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Learning Outcomes 1. Identify and explain the regulatory and statutory obligations which must be complied with by medical device industries operating in the EU and the US. 2. Evaluate device design inputs, and devise design outputs together with appropriate verification and validation procedures 3. Apply risk analysis methodologies (Failure Mode Effect Analysis and Fault Tree Analysis) to medical devices 4. Apply appropriate standards to devise biological evaluation test plans for biomaterials 5. Write well organised Technical file and Design dossier documents, in accordance with regulatory requirements as part of a team 6. Prepare a clear oral presentation summarising and justifying the compliance of a product with regulatory and statutory requirements. | |||||||||||||||||||||||||||||||||||||||||||
All module information is indicative and subject to change. For further information,students are advised to refer to the University's Marks and Standards and Programme Specific Regulations at: http://www.dcu.ie/registry/examinations/index.shtml |
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Indicative Content and Learning Activities
Medical Device Regulation 2017/745Device classifications, Essential Requirements, conformance routes. The Technical File.FDA Code of Federal RegulationsFDA Quality System requirements (QSRs) and GMPsCase Study: Carotid stent and embolic protection systemDevice characteristics and Intended Use, Indications, Contraindications, Clinical History, Pre-clinical Studies, In Vitro Product Testing, Animal Testing, Biocompatibility, Sterilisation, Summary of Clinical StudiesISO 13485 Quality systems for Medical DevicesDesign ControlsISO 14791Medical devices -- Application of risk management to medical devicesRisk AnalysisFailure Mode Evaluation Analysis (FMEA); Fault Tree Analysis (FTA); Case StudyISO 10993 Biological Evaluation of Medical DevicesEvaluation and testing within a risk management process; Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity; Part 4: Selection of tests for interactions with blood; Part 5: Tests for in vitro cytotoxicity; Part 12: Sample preparation and reference materialsSterilisationMethods, validationISO 9001:2008Quality management systems -- RequirementsPost Market Surveillance and Product DevelopmentFeed-back mechanism, Vigilance reportingTissue Engineering and Cell based TherapiesRegulatory Issues | |||||||||||||||||||||||||||||||||||||||||||
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Indicative Reading List
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Other Resources None | |||||||||||||||||||||||||||||||||||||||||||