The agency that clears all medical devices for commercialization.

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

A document giving instructions for manufacturing a medical device.

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

This type of protocol determines if equipment is installed correctly.

The process for making a change to a controlled procedure.

This states; 'We will consistently provide superior products and services in pursuit of our purpose of advancing the world of health."

Providing clear identification for each batch or lot of finished medical devices and their component parts through documentation and labeling to make any future investigations or corrective actions easier.

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.

Any written, electronic, or oral communication alleging a deficiency in identity, quality, durability, safety, effectiveness or performance of a medical device after it has been released for distribution.

The date listed on the a component or devices label when its quality can degrade over time.

The name of the department that controls procedures using Master Control.

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

The manufacturing documentation related to the production of a unique batch of product.

Proving using objective evidence that a process works and consistently produces its intended results.

The process of testing a piece of measuring equipment to ensure its measurements are reliable and repeatable.

Ensuring all written entries are clear and can be read.

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.

A tool to monitor and trend the variation of a manufacturing process in order to ensure products will meet requirements.

The process for evaluating if BD Glens Falls Operation is compliant with its procedures. The resulting report of this process is not reviewable by FDA.

The location any employee can place product or components with a suspected quality issue.

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.