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QM documents

Certificate_approval_quality_system_2014_31_EU

CERTIFICATE_DIN_EN_ISO_13485_Rev._03

CERTIFICATE_EN_ISO_13485_France_Rev._04

CERTIFICATE_ISO_27701-2025

CERTIFICATE_ISO_27001-2025

CERTIFICATE_ISO_9001-2015

ISO 13485-2016 MDSAP Certificate Rev. 04

EC_Certificate_Directive_93_42_EEC_Annex_II

EC_Certificate_Directive_93_42_EEC_Annex_VI

EMC_Recommendation_as_per_EN_60601-1-2_2007

EMC_Recommendation_as_per_EN_60601-1-2_2015

Bluetooth_Recommendation_EN_as_per_IEC 60601-1_2005+A1_2012+A2_2020

MDR EU QMS Certificate - Class IIa 2020

MDR EU QMS Certificate - Class Im 2021

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Whitepapers

Whitepaper Cyber Security 2024-03-12

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Whitepaper Cyber Security 2024-01-17