Complaint Investigation

ParanoiaIQ | Complaint Investigation 21 CFR 803 · ISO 13485 §8.2.2 · ISO 14971

New Investigation

Enter complaint data to run a full regulatory investigation assessment.

Authentication

Anthropic API Key *

Paste Complaint Text

Raw complaint narrative

Complaint ID (optional)

Date Received

Authentication

Anthropic API Key *

Complaint Record

Complaint ID

Date Received *

Product Name *

Catalog / Model

Lot / Serial

Event Date

Country

Reporter Type

Device Context (optional)

Time in Service (years)

Labeled Service Life (years)

A 10-year-old implant at end of labeled life carries different risk than a new device failing at month 3. When both fields are provided, the tool classifies the failure as end-of-life wear (≥80% of service life consumed), premature failure (≤30%), or mid-service — and adjusts the probability score accordingly. Source: Labeled service life from the device IFU or design specification. Time in service = date of event minus implant/first-use date.

Complaint History

Similar — 30 days

Similar — 12 months

Units Distributed (optional)

Clinical & Device

Patient Outcome *

Device Malfunction? *

Yes No

If malfunction recurred, could it cause serious injury or death? *

Yes No

Possible failure to meet specification? Device is an implant?

Event Description *

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Running investigation...

20–40 seconds · 7 regulatory tools

MDR Reportability (21 CFR 803.50)

Deadline Calculation

Risk Scoring (ISO 14971)

Investigation Requirement (ISO 13485 §8.2.2)

Trending Analysis (ISO 13485 §8.2.1 / §8.4)

CAPA Assessment (ISO 13485 §8.5.2)

Investigation Plan