---
title: "Manufacturing & Supply - MedTech Ecosystems"
description: "Process validation, design transfer, contract manufacturers, sterilization, UDI, and the supply-chain controls that keep finished devices flowing."
lang: en
json-ld:
---

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Ecosystem 

# Manufacturing & Supply

Process validation, design transfer, contract manufacturers, sterilization, UDI, and the supply-chain controls that keep finished devices flowing.

30 terms

## Regulatory2 

-   [Device Master File(MAF) ](/terms/device-master-file)
-   [Unique Device Identification(UDI) ](/terms/udi)

## Quality & Risk1 

-   [IQ / OQ / PQ ](/terms/iq-oq-pq)

## Standards4 

-   [ISO 11135 ](/terms/iso-11135)
-   [ISO 11137 ](/terms/iso-11137)
-   [ISO 11607-1/-2 ](/terms/iso-11607)
-   [ISO 17665 ](/terms/iso-17665)

## Manufacturing22 

-   [Bill of Materials(BOM) ](/terms/bom)
-   [Bioburden ](/terms/bioburden)
-   [Cleanroom Classes (ISO 14644) ](/terms/cleanroom-iso-14644)
-   [Container Closure Integrity(CCI) ](/terms/container-closure)
-   [Counterfeit Parts and Suspect Components ](/terms/counterfeit-parts)
-   [Design Transfer ](/terms/design-transfer)
-   [Device History Record(DHR) ](/terms/dhr)
-   [Device Master Record(DMR) ](/terms/dmr)
-   [Endotoxin Testing (LAL) ](/terms/endotoxin)
-   [Engineering Change Order / Notice(ECO / ECN) ](/terms/eco-ecn)
-   [Lot Traceability ](/terms/lot-traceability)
-   [MRP and ERP Systems(MRP / ERP) ](/terms/mrp-erp)
-   [Pre-Approval Inspection(PAI) ](/terms/pai)
-   [Process Capability (Cp/Cpk) and SPC ](/terms/spc-cpk)
-   [Process Capability and Cpk ](/terms/process-capability-cpk)
-   [Process Validation ](/terms/process-validation)
-   [Scrap Rate and Yield ](/terms/scrap-yield)
-   [Stability Testing ](/terms/stability-testing)
-   [Sterilization ](/terms/sterilization)
-   [Supplier Controls ](/terms/supplier-controls)
-   [Technology Transfer (Manufacturing) ](/terms/tech-transfer)
-   [UDI-DI vs. UDI-PI ](/terms/udi-di-pi)

## Commercialization1 

-   [Group Purchasing Organization(GPO) ](/terms/gpo)

### Other ecosystems

[Regulated Pathways](/ecosystems/regulated-pathways)[AI / ML in Devices](/ecosystems/ai-ml)[Connected & Cyber-Physical Devices](/ecosystems/connected-devices)[Software Lifecycle](/ecosystems/software-lifecycle)[Quality System](/ecosystems/quality-system)[Clinical Evidence](/ecosystems/clinical-evidence)[Post-Market & Safety](/ecosystems/post-market-safety)[Global Markets](/ecosystems/global-markets)[Hospital Buyer & Reimbursement](/ecosystems/hospital-buyer)[Startup Lifecycle](/ecosystems/startup-lifecycle)[Strategic Landscape](/ecosystems/strategic-landscape)

MedTech Terms 

An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices.

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Resources

-   [FDA Medical Devices](https://www.fda.gov/medical-devices)
-   [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj)
-   [IMDRF](https://www.imdrf.org/)
-   [Methodology](/methodology)
-   [Changelog](/changelog)
-   [Editor: Christian Espinosa](/authors/christian-espinosa)
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