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Tandem Health
|Trust CentreTandem Health develops solutions to reduce administration in healthcare. Our team combines healthcare expertise with AI, software, & data security expertise to meet the needs of healthcare providers across Europe.
Compliance Frameworks
Frameworks
ISO 13485:2016
Quality Management System (QMS) for medical devices
ISO 14001:2015
Environmental Management System (EMS) standard
ISO 27001:2022
Information Security Management Systems
ISO 42001:2023
Artificial Intelligence (AI) Management Systems
EU MDR (Class IIa)
EU Medical Device Regulation (Class IIa)
GDPR
General Data Protection Regulation
C5
Germany's Cloud Computing Compliance Criteria Catalogue
C5 Type 2 Report
ENS
Spain's national security framework
LVV A1 (formerly Valvira)
LVV Class A1 (formerly Valvira) Finnish regulatory classification
Ethik-IA
Label certifying ethical, human-overseen use of AI in healthcare
NEN 7510-1:2024
Dutch information security management standard for healthcare organisations
Cyber Essentials Plus
Cyber Essentials Plus audited certification
DTAC
NHS Digital Technology Assessment Criteria (v2)
NHS DTAC Scribe
NHS DTAC Coder
NHS DTAC Guide
DSPT
NHS Data Security and Protection Toolkit v8 (25/26) (Category 3 Organisation / Other)
DCB0129
NHS Digital Clinical Safety for Manufacturers
NHS Hazard Log Scribe
Published hazard log for Tandem AI Medical ScribeNHS Hazard Log Coder
Published hazard log for Tandem AI Medical CoderNHS Hazard Log Guide
Published hazard log for Tandem AI Medical GuideNHS CSCR Scribe 4.3
NHS CSCR Coder v 1.0
NHS CSCR Guide v 1.2