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Medtech - DEV CommunityNavigation menuSearchSearchCloseLeft menuRight menuCommentsCommentsCommentsCommentsCommentsCommentsCommentsCommentsCommentsCommentsCommentsCommentsCommentsCommentsComments - dev.to
How I validate LLMs for GxP work — scope, evidence, and the auditor's checklist
Priya Nair
Priya Nair
Priya Nair
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May 29
How I validate LLMs for GxP work — scope, evidence, and the auditor's checklist
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4 min read
Interoperability and connectivity: practical compliance for connected medical devices
Priya Nair
Priya Nair
Priya Nair
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May 29
Interoperability and connectivity: practical compliance for connected medical devices
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3 min read
510(k) clearance pitfalls — the weak links that actually stall approval
James Whitfield
James Whitfield
James Whitfield
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May 22
510(k) clearance pitfalls — the weak links that actually stall approval
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4 min read
Where usability files actually fail — and how to stop firefighting later
Priya Nair
Priya Nair
Priya Nair
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May 20
Where usability files actually fail — and how to stop firefighting later
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4 min read
Why interoperability failures are a product problem — and how to stop firefighting later
Priya Nair
Priya Nair
Priya Nair
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May 20
Why interoperability failures are a product problem — and how to stop firefighting later
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4 min read
Why our eQMS ran in parallel for 18 months — and what I’d do differently
James Whitfield
James Whitfield
James Whitfield
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May 19
Why our eQMS ran in parallel for 18 months — and what I’d do differently
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4 min read
Why our eQMS ran in parallel for 18 months — and what I’d do differently
James Whitfield
James Whitfield
James Whitfield
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May 19
Why our eQMS ran in parallel for 18 months — and what I’d do differently
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4 min read
Quality culture vs quality theatre — what inspectors actually see
Priya Nair
Priya Nair
Priya Nair
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May 19
Quality culture vs quality theatre — what inspectors actually see
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4 min read
CE marking under MDR — what's actually new, and what teams still get wrong
Priya Nair
Priya Nair
Priya Nair
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May 14
CE marking under MDR — what's actually new, and what teams still get wrong
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3 min read
How MDR vs IVDR changes the CAPA game (and what I actually changed in our QMS)
James Whitfield
James Whitfield
James Whitfield
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May 26
How MDR vs IVDR changes the CAPA game (and what I actually changed in our QMS)
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4 min read
CE under MDR — what's actually new (and what teams still get wrong)
James Whitfield
James Whitfield
James Whitfield
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May 13
CE under MDR — what's actually new (and what teams still get wrong)
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4 min read
MDR reform (Dec 2025): what the new “breakthrough” pathways mean for small medtech teams
Priya Nair
Priya Nair
Priya Nair
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May 26
MDR reform (Dec 2025): what the new “breakthrough” pathways mean for small medtech teams
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4 min read
AI in QMS — what it actually does, and what vendors mean by “AI”
Priya Nair
Priya Nair
Priya Nair
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May 11
AI in QMS — what it actually does, and what vendors mean by “AI”
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4 min read
Why Europe still has no MAUDE equivalent — the transparency gap and what to do about it
Priya Nair
Priya Nair
Priya Nair
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May 11
Why Europe still has no MAUDE equivalent — the transparency gap and what to do about it
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4 min read
SaMD and the regulatory gap: why software still trips up notified bodies
Priya Nair
Priya Nair
Priya Nair
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May 7
SaMD and the regulatory gap: why software still trips up notified bodies
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3 min read
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