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Regulatory Compliance

inHEART leads in cardiac innovation by upholding the highest standards of quality, safety, cybersecurity and regulatory compliance. Our dedication to protecting patients and driving progress means we consistently surpass international requirements, delivering secure, reliable, and advanced digital solutions to healthcare professionals worldwide.

Europe

ISO 13485 Certificate

CE Certificate

USA

510(k) Clearance

SOC 2 Type 2

HIPAA Compliance

Australia

ARTG Certificates

UK

PARD Registration

Switzerland

Swissdamed Registration

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