Medical Device Manufacturing Glossary

Independent · source-linked · manufacturing-first

Medical manufacturing combines engineering, quality and regulatory language. This glossary gives each term a practical boundary and links readers back to the authoritative source when the definition has legal or regulatory weight.

Use the current source

Regulatory definitions and obligations can change. FDA regulations, guidance and databases control U.S. requirements; ISO and standards organizations control their published standards. MBB supplies navigation and manufacturing context, not a substitute for those texts.

Keep similar words separate

Verification asks whether specified requirements were met. Validation asks whether the result or process is fit for its intended use. Calibration establishes metrological relationships for equipment. These activities can support one another but are not interchangeable.

Core terms

510(k)

A premarket submission used to demonstrate substantial equivalence to a legally marketed predicate when the pathway applies.

Additive manufacturing

Layer-by-layer fabrication; in medical devices it carries design, build-process, post-processing and testing considerations.

Device history record

Records demonstrating that a device or lot was manufactured according to the applicable production requirements and specifications.

GUDID

FDA's Global Unique Device Identification Database, which stores key device identification information submitted by labelers.

PMA

Premarket Approval, FDA's most stringent device marketing application pathway for applicable Class III devices.

QMSR

FDA's Quality Management System Regulation, effective February 2, 2026, incorporating ISO 13485:2016 by reference.

Reprocessing

Validated cleaning followed by disinfection or sterilization, as appropriate, for a reusable medical device.

Special process

A process whose result may not be fully verified by later inspection and therefore requires controlled validation and monitoring where applicable.

UDI

A unique device identifier, generally comprising a device identifier and applicable production identifiers.

Validation

Documented evidence that a process, method or system consistently fulfills its defined intended requirements.

Continue the medical manufacturing map

Independent educational reference: Machine Blue Book is not affiliated with Arthrex, FDA, ISO or any manufacturer named on this page. Names are used descriptively and linked to primary sources. This material is not medical, legal, regulatory or clinical advice and does not recommend a device for patient care.