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Search published PV Bulletin articles and safety signals by topic, regulator, workflow, company, tag, or source.

Found 3 result(s) for "Signal Management".

Showing 1-3 of 3 published article match(es)

publicFda · Updated May 22, 2026

FDA ties TRUE METRIX Safety Communication to Class I recall update

Urgency: High

Fda update requires triage for Signal Validation, Local Affiliate Compliance, Device Vigilance; confirm local obligations and document follow-up actions.

Signal ValidationLocal Affiliate ComplianceLocal Safety Officer
SOP Impact7 SOPs
ConfidenceMedium
Relevant for: Local Safety Officer, Signal Management Lead, Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
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publicMhra · Updated Apr 29, 2026

MHRA issues April 2026 Safety Roundup for medicines and devices

Urgency: Medium

Mhra update requires triage for Signal Validation, Local Affiliate Compliance, Device Vigilance; confirm local obligations and document follow-up actions.

Signal ValidationLocal Affiliate ComplianceLocal Safety Officer
SOP Impact5 SOPs
ConfidenceMedium
Relevant for: Local Safety Officer, Signal Management Lead, Regulatory Intelligence Lead
verifiedRegulatory action: Devices
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publicTga · Australia · Updated May 24, 2026

Australia: TGA refreshes device post-market monitoring hub and responsibilities

Monitoring

1) Add/confirm the TGA 'medical device post-market monitoring and safety updates' page as a tracked regulatory intelligence source for routine review. 2) Cross-check internal Australia device vigilance SOPs/work instructions against TGA guidance on sponsor/manufacturer post-market responsibilities and document any gaps for CAPA/change control as needed.

Signal ValidationLocal Affiliate ComplianceLocal Safety Officer
SOP Impact5 SOPs
ConfidenceMedium
Relevant for: Local Safety Officer, Signal Management Lead, Regulatory Intelligence Lead
verifiedRegulatory action: Devices
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