Latest Module Specifications
Current Academic Year 2025 - 2026
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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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 2017/745 Device classifications, Essential Requirements, conformance routes. The Technical File. FDA Code of Federal Regulations FDA Quality System requirements (QSRs) and GMPs Case Study: Carotid stent and embolic protection system Device characteristics and Intended Use, Indications, Contraindications, Clinical History, Pre-clinical Studies, In Vitro Product Testing, Animal Testing, Biocompatibility, Sterilisation, Summary of Clinical Studies ISO 13485 Quality systems for Medical Devices Design Controls ISO 14791 Medical devices -- Application of risk management to medical devices Risk Analysis Failure Mode Evaluation Analysis (FMEA); Fault Tree Analysis (FTA); Case Study ISO 10993 Biological Evaluation of Medical Devices Evaluation 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 materials Sterilisation Methods, validation ISO 9001:2008 Quality management systems -- Requirements Post Market Surveillance and Product Development Feed-back mechanism, Vigilance reporting Tissue Engineering and Cell based Therapies Regulatory Issues | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Indicative Reading List Books:
Articles:
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Other Resources None | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||