The agency that clears all medical devices for commercialization.

This is also known as Good Manufacturing Practices for Medical Devices.

In Prelude MD, what does the MD stand for?

The two acceptable colors of ink to be used on documentation.

This type of protocol determines if equipment is installed correctly.

The process for making a change to a controlled procedure.

Your ID badge also comes with a second badge with this written on it.

A standard test voltage is applied for a specified amount of time and the resulting current leakage is measured against a specification based on the device.

Cross out with a single line, initial, and date

This type of protocol determines if an instrument is operating in a consistent and repeatable manner.

The process for correcting needed Quality System “fixes” in the organization.

The report of a possible failure of a device, labeling, or packaging to meet any of its specifications.

The name of the plan written that explains how medical devices will be manufactured.

The name of the department that controls procedures using ProductCenter Software.

This regulation outlines the requirements for Electronic Records and Electronic Signatures.

The regulation that mandates the implementation of Good Manufacturing Practices for medical devices.

The Management Representative for Thermo Fisher San Jose.

Thermo Fisher's mass spectrometry product that will be registered as a medical device.

The record that contains manufacturing information for a specific device.

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.

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.

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.

The set of "tools" that assist in the identification and steady elimination of waste in the manufacturing process.

To make a planned or unplanned deviation/change to a process, this is used.

Software is designed by in-house engineers and is considered a high operational risk by FDA.