What question did this study set out to answer?

The aim is to provide a toolkit that assists in governing requirements throughout their lifecycle in the medical device sector, addressing regulatory compliance and usability.

August 6, 2026Open Access

Requirements Lifecycle Governance Toolkit for FDA-Regulated Medical Devices

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Authors

LSLulin Shan

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Implication

Toolkit develops governance patterns for requirements management in FDA-regulated medical device development, suggesting improvements in quality system adherence.

Key Points

The aim is to provide a toolkit that assists in governing requirements throughout their lifecycle in the medical device sector, addressing regulatory compliance and usability.
Developed reusable patterns for requirement governance, including templates and checklists.
Grounded in FDA design control requirements and human-centered design practices.
Adaptable to organizational quality systems and device classes.
Toolkit includes five governance patterns and templates for requirements and traceability.
Waste prevention measures are integrated through an error-prevention checklist.
Usability validation methods are included to enhance governance processes.

Cite This Study

Lulin Shan (2026) studied this question.

synapsesocial.com/papers/6a7437c8764cddc9499d5682 https://doi.org/10.17605/osf.io/eknyg

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Implication

Toolkit develops governance patterns for requirements management in FDA-regulated medical device development, suggesting improvements in quality system adherence.

Requirements Lifecycle Governance Toolkit for FDA-Regulated Medical Devices

Discussion

Member takes

Implication

Key Points

Cite This Study

Requirements Lifecycle Governance Toolkit for FDA-Regulated Medical Devices

Discussion

Member takes

Implication

Key Points

Cite This Study

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