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HalseyYang
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global-device-safety-surveillance

Investigates public post-market safety records for medical devices across FDA, EU, and other regulator databases.

1|Updated Jul 13, 2026
Search Tags:#recall#fda#medical device#post-market surveillance#regulatory affairs#adverse events#fsca
One-click install
npx skills add https://github.com/HalseyYang/Skills-HY --skill global-device-safety-surveillance-halseyyang
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: global-device-safety-surveillance
Source: https://github.com/HalseyYang/Skills-HY/tree/main/global-device-safety-surveillance
Command: npx skills add https://github.com/HalseyYang/Skills-HY --skill global-device-safety-surveillance-halseyyang

SYSTEM DOCUMENTATION & REQUIREMENTS

What problem does it solve? Gathering post-market safety evidence for a medical device requires manually searching many regulator databases (FDA adverse events, recalls, EU FSCA/FSN notices, TGA, Health Canada, Swissmedic), resolving device identity first, and keeping exact-device, product-family, and device-class evidence separate. This Skill automates that workflow and produces an auditable, source-backed surveillance summary suitable for CER/PMS/PSUR support. ## Core Features & Use Cases - Product identity resolution: Builds a structured Product Identity Object from names, models, UDI, FDA product codes, or 510(k)/PMA numbers before any safety search, with confidence scoring. - Multi-jurisdiction retrieval: Queries FDA adverse-event sources (with runtime AEMS/MAUDE/openFDA resolution), FDA recalls, TPLC, EUDAMED, EU Member State safety notices, and optional AU/CA/CH/UK sources. - Evidence governance: Separates exact-device, product-family, and device-class records, de-duplicates cross-authority FSCAs, keeps a full search audit trail, and applies a three-pass QA gate. - Use Case: Provide a device brand and manufacturer, and receive a formal DOCX surveillance report plus an XLSX audit workbook documenting every query, count, and safety-signal assessment. ## Quick Start Run a full global post-market safety surveillance for the device [brand name] from [manufacturer] covering the last five years and produce the formal report and audit workbook.

Frequently Asked Questions about global-device-safety-surveillance

High-intent search queries and answers about installing and using this skill.

FAQPage Schema
How do I search FDA adverse events for a medical device?▼

Provide the device name, model, manufacturer, UDI, or FDA product code, and the skill resolves the device identity first, then queries the current FDA adverse-event infrastructure (AEMS when available, otherwise MAUDE/openFDA Device Event). Results are de-duplicated and split into exact-device, product-family, and device-class scopes.

What databases does a global medical device safety search cover?▼

Coverage includes FDA adverse events, recalls, TPLC, and safety communications; EUDAMED and EU Member State FSCA/FSN notices (BfArM, AEMPS, ANSM); plus optional TGA DAEN/DRAC, Health Canada incidents and recalls, Swissmedic FSCAs, and UK safety notices.

Can MAUDE report counts be used as adverse-event rates?▼

No. Spontaneous report databases like MAUDE, DAEN, and MDI lack an exposure denominator, so counts cannot be converted into incidence rates or used for comparative safety claims. The skill reports counts only with explicit caveats and date windows.

Does EUDAMED provide a public EU-wide incident database?▼

Not currently for vigilance. The skill verifies EUDAMED module status at runtime and, when the Vigilance/PMS module is not public, relies on Member State competent-authority safety notices and FSCAs while explicitly stating this limitation.

What inputs are needed to run a device safety surveillance search?▼

Any combination of product name, brand, model, manufacturer, intended use, IFU text, UDI-DI, FDA product code, or 510(k)/PMA/De Novo number works. If identity is ambiguous, searches run across plausible candidates with results kept separate.

What deliverables does a full surveillance run produce?▼

A Full Audit Surveillance produces a formal DOCX report with a safety-signal matrix and search audit trail, plus an XLSX audit workbook containing the product identity, search log, raw and included records, recalls/FSCAs, and QA status.

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