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FDA 21 CFR Part 820.30
Design Controls
1
1
CFR Title 21, Volume 8, Section 820.30(a)(2)

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ISO 13485:2016 Section 7.3
Standard
EU MDR Annex II Requirements
Regulation
FDA Guidance on Software
Guidance

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Purpose-built tools for predicate identification, gap analysis, technical file compilation, literature review.

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Predicate ID
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Gap Analysis
In Progress
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Technical File - Section 4.2
3 team comments
JD
Updated the risk analysis
2m ago
SM
Added FDA reference
5m ago
AK
Reviewed predicate device
12m ago
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