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September 10, 2025Journal of Clinical and Nursing ResearchOpen Access

The Critical Role and Practice of Medical Device Design and Development Documentation in Quality Systems

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Authors

MHMiao HeGuangzhou Regenerative Medicine and Health Guangdong Laboratory

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Overview

This work identifies how development documentation ensures regulatory compliance and aids in risk management.

Key Points

  • Effective medical device design documentation ensures compliance with regulatory standards, supporting quality systems.
  • It serves as a traceable record, facilitating risk management and supporting all development stages.
  • Document template creation and review association are vital for maintaining organized information management.
  • Addressing differences in international declarations is essential for effective adverse event traceability.

Cite This Study

Miao He (2025) studied this question.

synapsesocial.com/papers/68c192659b7b07f3a0617479https://doi.org/10.26689/jcnr.v9i8.11772
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  5. 5Synergizing Design for Manufacturability (DfM) and Quality by Design (QbD) to Optimize Product Development in Medical Device Manufacturing2025