Glossary:TAG-00165-Sys-omb

Glossary > Device system

Device system
Tag-ID	TAG-00165-Sys-omb
English	System / Combined device system
French	Système / Système de dispositifs combinés
German	System / Produktsystem / Kombiniertes Gerätesystem

References

	Scope	Document part	Language	Document
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023 Article 2 Paragraph 10 – 12	MD	Article 2 Paragraph 10 – 12	EN	EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023
ICH ICH E6 Guideline R3 (2025) GLOSSARY - Computerised Systems Validation	G	GLOSSARY - Computerised Systems Validation	EN	ICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.12.10	G	III. Annex 1 2.12.10	EN	ICH ICH E6 Guideline R3 (2025)
USA 21 CFR Part 11 09-Apr-2025 § 11.200	G	§ 11.200	EN	USA 21 CFR Part 11 09-Apr-2025
USA 21 CFR Part 11 09-Apr-2025 § 11.300	G	§ 11.300	EN	USA 21 CFR Part 11 09-Apr-2025