The government agency that clears all medical devices for commercialization.

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

The standard operating procedure defining the requirements for entering the controlled manufacturing area.

Do use these two acceptable colors of ink on records.

These cover your shoes when entering controlled manufacturing areas to limit particulate in sensitive areas.

The process for making a change to a controlled procedure.

"We will consistently provide superior products and services in pursuit of advancing the world of health"

A label on a piece of measure and test equipment providing equipment identity and when it was last evaluated for reliability.

Don't scribble or use white out. Instead do cross out with a single line, initial, and date during this process.

A process completed at the beginning and end of shifts and in between lots to kill bacteria that might be present on manufacturing surfaces.

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

Any oral or written report of a product in distribution that may have failure of device, labeling, packaging, or any of its specifications.

A written document giving the specific task instructions to manufacture a medical device.

Do return old revisions of procedures to this department.

A simple accessory that keeps hair away from contaminating products or the manufacturing environment.

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

The totality of a products features and characteristics that satisfy fitness for use, including safety and performance. Responsibility for this fall to everyone.

The time frame in which a material, component or finished device is intended to be used.

Do fill in all documents completely. Don't leave these unexplained gaps on a record.

The space dividing a cleanroom or a controlled manufacturing area from a common use area such as offices/locker rooms or cafeterias.

A lot of product manufactured under quarantine to be used for testing or validation and not for human use.

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

The process of eliminating bioburden (aka germs) on a finished medical device. GFO uses Ethylene Oxide and E-Beam types.

Do follow all manufacturing procedures as written during the manufacture of product for distribution. Don't deviate from the procedure unless approved by this.

The process of eliminating bioburden (germs) on a finished medical device.