Document management for medical device development
DOI:
https://doi.org/10.56162/transdigital340Keywords:
document management, medical devices, product life cycle, project managementAbstract
Development projects focused on creating medical devices aim to design and develop, highly regulated products to ensure safety and effectiveness of their intended use. As a result, manufacturers must incorporate documentary evidence of their processes throughout the life cycle phases. This work presented a document management framework to encompass the product life cycle, project management principles, quality control and documentation. The findings highlighted that the use of a document management structure positively impacts the organization, traceability, and quality of the project. This contributes to the advancement of document management practices in medical device development projects and sets a benchmark for future developments in this field.
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Copyright (c) 2024 Cristina Alejandra Cázares-Sánchez, Fernando Sebastián Chiwo-González, John Edison García-Herrera, Isaías Garduño-Olvera, Javier Méndez Lozoya
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