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Sample Glossary Extract

Sample Glossary Extract (abbreviated sample)

This short sample illustrates the format and structure of a Sesen medical device glossary. Full glossaries include expanded term sets, additional languages, and references to relevant regulatory modules.

Term

Definition

French

German

Module Reference

Unique Device Identifier (UDI)

Numeric or alphanumeric code to identify medical devices

Identifiant unique du dispositif

Eindeutige Gerätekennung

Device Labeling

Instructions for Use (IFU)

Document provided with a medical device that explains safe use

Notice d’utilisation

Gebrauchsanweisung

IFU Documentation

Adverse device effect

Undesirable effect linked to the use of a device

Effet indésirable lié au dispositif

Gerätbedingte Nebenwirkung

Vigilance Reporting

Post-market surveillance (PMS)

Monitoring of device safety and performance after release

Surveillance après commercialisation

Marktüberwachung

PMS Report

Biocompatibility

Ability of a material to perform with an appropriate host response

Biocompatibilité

Biokompatibilität

Risk Assessment Report

Residual risk

Risk remaining after risk control measures have been applied

Risque résiduel

Restrisiko

Risk Management File

Shelf life

Period during which a medical device remains safe and effective

Durée de conservation

Haltbarkeit

Packaging & Labeling

Conformity assessment

Procedure to demonstrate compliance with MDR/IVDR requirements

Évaluation de conformité

Konformitätsbewertung

Regulatory Submission

Formats available: CSV, TBX, XLSX

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Standards & Compliance

Standards & Compliance

Sesen’s Medical Device Glossaries are aligned with key international standards and regulatory frameworks, including MDR, IVDR, ISO 15223, FDA device labeling requirements, and EMA guidance. All terminology is managed in compliance with ISO 17100 for translation quality, ensuring accuracy, consistency, and regulatory readiness across all markets.

Related Resources

Related Resources

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For organizations with specialized devices or regulatory requirements, Sesen offers custom glossary development. Our team creates glossaries aligned with MDR, IVDR, FDA, ISO 15223, and other regulatory frameworks, tailored to your product portfolio and markets. Glossaries are integrated into your translation workflows to reduce review cycles, improve compliance, and enhance clarity for end users.

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