WWTFDAD (What Would the FDA Do)
This is the number of calendar days Teleflex has to submit an MDR when a malfunction could cause or contribute to serious injury if it recurred.
What is 30 days?
Before EUDAMED is fully functional, manufacturers must notify these entities directly of serious incidents
What is the Competent Authority?
This document captures objective evidence when the manufacturer cannot provide a detailed manufacturing investigation.
What is a Certificate of Conformance/lot release evidence? AKA DHR
This foundational document auditors commonly request first to understand your complaint handling process.
What is the SOP (e.g., complaint handling or vigilance procedure)?
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What is Africa?
This type of MDR is triggered when the company becomes aware of a reportable event requiring immediate corrective action.
What is a 5‑day MDR?
These countries adhere to MEDDEV 2.12/1 rev 8 for Post Market Surveillance and Vigilance.
Great Britain (England, Wales and Scotland) and Northern Ireland
Complaints requiring regulatory assessment cannot be closed until this is documented.
What is the final reportability decision?
During an MDSAP audit, auditors often pull these records to verify timely and accurate decision-making.
What are complaint files?
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What is Mexico City?
A voluntary report that can be submitted that includes the reporting of adverse events, product use/medication errors, product quality problems, and therapeutic failures.
MedWatch
This document summarizes the main risks and safety outcomes for Class IIa, IIb, and III devices, requiring update at least annually.
What is the Periodic Safety Update Report (PSUR)?
When device samples are unavailable for inspection, this investigative approach is used.
What is a document-based investigation?
Auditors often test this “vertical slice" method where they choose a complaint and trace it through all related systems.
What is a tracing or linkage audit trail?
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What is a Labubu?
Publicly searchable database of adverse event reports.
Manufacturer and User Facility Device Experience (MAUDE)
These are the four risk-based classifications for medical devices under the MDR.
What are Class I, IIa, IIb, and III?
This type of root cause is assigned when available evidence cannot confirm failure mode, use error, or process issues.
What is undetermined?
The 5 countries that make up the MDSAP audit program
What are US, Canada, Brazil, Japan, Australia?
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What is 'Wicked'?
FDA requires MDRs to be submitted in this electronic format using the FDA gateway.
What is the eMDR?
This name is for a conformity assessment body designated in accordance with MDR 2017/745. It is responsible for enforcing the regulation in their country.
Notified Body
To ensure complaints remain audit-ready, these three elements must always be complete and aligned (name at least two).
What are investigation, risk assessment, regulatory decision, documentation, closures?
MDSAP auditors frequently verify whether this system has been updated when trends indicate repeated issues.
What is the Corrective and Preventive Action (CAPA) system?
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Who is Rumi?