WWTFDAD (What Would the FDA Do)
The Federal Regulation which Medical Device companies need to adhere to.
CFR - Code of Federal Regulations Title 21
A marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in MDR 2017/745 and other applicable Union harmonization legislation providing for its affixing.
CE marking of conformity or CE marking
The date that any Teleflex employee or representative first becomes aware of a complaint and/or adverse event, always a specific day, month, year. Unless otherwise required by a regulatory authority, the Teleflex aware date is day zero (Clock Starts) for meeting regulatory reporting requirements.
Teleflex Aware Date
A compilation of records containing the production history of a finished device.
Device History Record (DHR)
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Cliffs Of Moher
The failure of a device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device.
What is a Malfunction
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
Consists of a device identifier (DI) and production identifier(s) (PI) as appearing on the device label or the direct part mark (DPM) of the device.
UDI (Unique Device Identification)
EMEA
Europe, Middle East and Africa
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San Francisco 49ers
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
Countries that belong to the European Union (EU) and the European Economic Area (EEA) follow this regulation.
MDR Regulation (EU) 2017/745
This task code is used and assigned to a designated person when additional information has been received.
360, Additional Information Received.
All phases in the life of a medical device, from the initial conception to final decommissioning and disposal.
Product Lifecycle Management (PLM)
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Jennifer Lopez
Publicly searchable database of adverse event reports.
Manufacturer and User Facility Device Experience (MAUDE)
Manufacturers should submit this type of report immediately after they have established the causal relationship between that incident and their device or that such causal relationship is reasonably possible and not later than 15 days after they become aware of the incident.
Serious Incident
If you want to learn more about Adverse Event Reporting, be sure to check out this process document...
D0003165, Adverse Event Reporting
Information provided by the manufacturer to inform the user of a device’s intended purpose and proper use, and of any precautions to be taken.
Instructions for Use (IFU)
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Lady Gaga
Is life-threatening, results in permanent impairment of a body function or permanent damage to a body structure, or necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure. Permanent means irreversible impairment or damage to a body structure or function, excluding trivial impairment or damage.
Serious Injury
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
Non-fulfilment of a documented requirement (unplanned deviation) or potentially a missing requirement. This applies to a product before and after distribution and or a process.
Non-Coformance (NC)
SPHT
Serious Public Health Threat (Any event type which results in imminent risk of death, serious deterioration in state of health, or serious illness that requires prompt remedial action)
What famous "Sir" had varied accomplishments such as being the first to introduce Ireland to potatoes and the person who gave Virginia its name?
Sir Walter Raleigh