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How I validate LLMs for GxP work — scope, evidence, and the auditor's checklist
priya_nair_ree profile

How I validate LLMs for GxP work — scope, evidence, and the auditor's checklist

#qms #medtech #compliance #regulatory
Comments
4 min read
Interoperability and connectivity: practical compliance for connected medical devices
priya_nair_ree profile

Interoperability and connectivity: practical compliance for connected medical devices

#qms #medtech #compliance #regulatory
Comments
3 min read
510(k) clearance pitfalls — the weak links that actually stall approval
jwithfield_qa profile

510(k) clearance pitfalls — the weak links that actually stall approval

#qms #medtech #regulatory #compliance
Comments
4 min read
Where usability files actually fail — and how to stop firefighting later
priya_nair_ree profile

Where usability files actually fail — and how to stop firefighting later

#qms #medtech #compliance
Comments
4 min read
Why interoperability failures are a product problem — and how to stop firefighting later
priya_nair_ree profile

Why interoperability failures are a product problem — and how to stop firefighting later

#qms #medtech #compliance #regulatory
Comments
4 min read
Why our eQMS ran in parallel for 18 months — and what I’d do differently
jwithfield_qa profile

Why our eQMS ran in parallel for 18 months — and what I’d do differently

#qms #medtech #compliance
Comments
4 min read
Why our eQMS ran in parallel for 18 months — and what I’d do differently
jwithfield_qa profile

Why our eQMS ran in parallel for 18 months — and what I’d do differently

#qms #medtech #compliance
Comments
4 min read
Quality culture vs quality theatre — what inspectors actually see
priya_nair_ree profile

Quality culture vs quality theatre — what inspectors actually see

#qms #medtech #compliance
Comments
4 min read
CE marking under MDR — what's actually new, and what teams still get wrong
priya_nair_ree profile

CE marking under MDR — what's actually new, and what teams still get wrong

#qms #medtech #regulatory
Comments
3 min read
How MDR vs IVDR changes the CAPA game (and what I actually changed in our QMS)
jwithfield_qa profile

How MDR vs IVDR changes the CAPA game (and what I actually changed in our QMS)

#qms #medtech #compliance #regulatory
Comments
4 min read
CE under MDR — what's actually new (and what teams still get wrong)
jwithfield_qa profile

CE under MDR — what's actually new (and what teams still get wrong)

#qms #medtech #regulatory
Comments
4 min read
MDR reform (Dec 2025): what the new “breakthrough” pathways mean for small medtech teams
priya_nair_ree profile

MDR reform (Dec 2025): what the new “breakthrough” pathways mean for small medtech teams

#medtech #regulatory #compliance
Comments
4 min read
AI in QMS — what it actually does, and what vendors mean by “AI”
priya_nair_ree profile

AI in QMS — what it actually does, and what vendors mean by “AI”

#qms #medtech #compliance #regulatory
Comments
4 min read
Why Europe still has no MAUDE equivalent — the transparency gap and what to do about it
priya_nair_ree profile

Why Europe still has no MAUDE equivalent — the transparency gap and what to do about it

#qms #medtech #regulatory
Comments
4 min read
SaMD and the regulatory gap: why software still trips up notified bodies
priya_nair_ree profile

SaMD and the regulatory gap: why software still trips up notified bodies

#qms #medtech #regulatory
Comments
3 min read
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