The agency that clears all medical devices for commercialization.
What is FDA
100
This is also know as Good Manufacturing Practices for Medical Devices.
What is Quality System Regulation
100
Besides the Endura, what is the other device that Thermo Fisher San Jose will register as a medical device?
What is Prelude
100
These are the two acceptable colors of ink to be used on documentation.
What is blue or black
100
This type of protocol determines if an instrument is installed correctly.
What is IQ (Installation Qualification)
200
The process for making a change to a controlled procedure.
What is ECO
200
Your ID badge also comes with a second badge with this written on it.
What is Quality Policy
200
This test determines how much voltage a Prelude or Endura can take without damaging the instrument.
What is Hi-Pot
200
Cross a single line through the error, initial, and date
What is how to correct a document error
200
This type of protocol determines if an instrument is operating in a consistent and repeatable manner.
What is OQ (Operational Qualification)
300
The process for correcting needed Quality System “fixes” in the organization.
What is CAPA
300
The report of a possible failure of a device, labeling, or packaging to meet any of its specifications.
What is Complaint
300
The name of the plan written that explains how medical devices will be manufactured.
What is Manufacturing Plan
300
The name of the department that controls procedures using ProductCenter Software.
What is Document Control
300
This regulation outlines the requirements for Electronic Records and Electronic Signatures.
What is CFR Part 11
400
The regulation that mandates the implementation of Good Manufacturing Practices for medical devices.
What is QSR
400
The Management Representative for Thermo Fisher San Jose.
What is the Quality Director
400
Thermo Fisher's mass spectrometry product that will be registered as a medical device.
What is Endura
400
The record that contains manufacturing information for a specific device.
What is Device History Record (DHR)
400
This type of validation is defined as establishing through documented evidence a high degree of assurance that a specific process will consistently produce a product that meets its predetermined specifications and quality characteristics.
What is Process Validation
500
Key tools used in this methodology include run charts and Design of Experiments. An example where these tools may be applied is in product manufacturing.
What is SPC
500
The process for evaluating if Thermo Fisher San Jose is compliant with its procedures. The resulting report of this process is not reviewable by FDA.
What is Internal Audit
500
The set of "tools" that assist in the identification and steady elimination of waste in the manufacturing process.
What is Lean Manufacturing?
500
Seven years or the life of the product.
What is the mandated retention period for medical device history records?
500
This type of software is designed by in-house engineers and is considered by FDA as a high risk requiring software validation.