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Your progress 0 of 14 lessons complete · up next: Process Validation [Start path](/terms/process-validation?from=manufacturing-and-supply-chain) 1. 1 [ Manufacturing ## Process Validation Establishing documented evidence that a process consistently produces conforming output. Why this term here: The umbrella concept: prove your process consistently produces conforming devices. ](/terms/process-validation?from=manufacturing-and-supply-chain)Mark done 2. 2 [ Quality & Risk ## IQ / OQ / PQ Installation, Operational, and Performance Qualification - the three stages of equipment and process qualification. Why this term here: The three-stage validation vocabulary you will use every day. ](/terms/iq-oq-pq?from=manufacturing-and-supply-chain)Mark done 3. 3 [ Manufacturing ## Sterilization Validated process used to render a device free from viable microorganisms. Why this term here: Method selection drives materials, packaging, and validation approach. ](/terms/sterilization?from=manufacturing-and-supply-chain)Mark done 4. 4 [ Standards ## ISO 11135 Standard for development, validation, and routine control of ethylene oxide (EO) sterilization. Why this term here: The primary standard when EO is the sterilization method. ](/terms/iso-11135?from=manufacturing-and-supply-chain)Mark done 5. 5 [ Manufacturing ## Cleanroom Classes (ISO 14644) ISO 14644 classification of cleanrooms by airborne particulate cleanliness (ISO 1 through ISO 9). Why this term here: Particulate class requirements and monitoring cadence. ](/terms/cleanroom-iso-14644?from=manufacturing-and-supply-chain)Mark done 6. 6 [ Quality & Risk ## Biocompatibility Ability of a material to perform with an appropriate host response in a specific application. Why this term here: The endpoint-driven testing program tied to contact category and duration. ](/terms/biocompatibility?from=manufacturing-and-supply-chain)Mark done 7. 7 [ Standards ## ISO 10993-1 Biological evaluation of medical devices within a risk management process. Why this term here: The evaluation framework that scopes which biocompatibility tests apply. ](/terms/iso-10993-1?from=manufacturing-and-supply-chain)Mark done 8. 8 [ Quality & Risk ## Shelf Life Period during which a device remains suitable for its intended use under specified conditions. Why this term here: How long the labeled sterile / functional claim holds. ](/terms/shelf-life?from=manufacturing-and-supply-chain)Mark done 9. 9 [ Manufacturing ## Stability Testing Studies that establish how device performance and packaging hold up over time. Why this term here: The accelerated and real-time studies that support shelf-life claims. ](/terms/stability-testing?from=manufacturing-and-supply-chain)Mark done 10. 10 [ Manufacturing ## Supplier Controls Procedures to ensure purchased products and services conform to requirements. Why this term here: The QMS clauses that determine how much rigor your suppliers get. ](/terms/supplier-controls?from=manufacturing-and-supply-chain)Mark done 11. 11 [ Quality & Risk ## Change Control Formal QMS process for evaluating, approving, and implementing changes that could affect product quality or compliance. Why this term here: The gate that keeps unvalidated changes out of production. ](/terms/change-control?from=manufacturing-and-supply-chain)Mark done 12. 12 [ Manufacturing ## Design Transfer Translating design into production specifications. Why this term here: The handoff most quality issues can be traced back to. ](/terms/design-transfer?from=manufacturing-and-supply-chain)Mark done 13. 13 [ Quality & Risk ## Nonconformance (NCR)(NCR) Failure of a product, process, or system to meet specified requirements. Why this term here: How manufacturing captures deviations and feeds them into CAPA. ](/terms/nonconformance?from=manufacturing-and-supply-chain)Mark done 14. 14 [ Manufacturing ## Lot Traceability Ability to trace materials, processes, and devices forward and backward through the supply chain by lot number. Why this term here: The end-to-end lineage regulators expect during recall investigations. ](/terms/lot-traceability?from=manufacturing-and-supply-chain)Mark done Finished the path? Test yourself with a quiz tailored to these 14 terms. [Take the Manufacturing & Supply Chain quiz](/quiz?path=manufacturing-and-supply-chain) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) 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) - [About this site](/about) © 2026 MedTech Terms. Reference content for educational purposes - not regulatory advice. A community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com)