Certified AI-powered diagnostics and treatment
Compliance built-in
Our products and quality management system are developed, tested, and certified according to highest industry standards. Our experience as medical device manufacturer ensures the highest level of compliance, safety, data protection, and performance.
Class II(b) EU MDR CE-mark
Class II(b) EU MDR CE-mark
PMcardio platform is a certified Class II(b) medical device under EU MDR 2017/745, meeting the highest standards in risk management, clinical testing, and technical performance.
It is independently certified by TÜV SÜD.
GDPR Compliant
GDPR compliant
We have aligned our privacy program with the GDPR, widely regarded as the most stringent global privacy standard, as well as other global regulations. The GDPR governs the collection and use of EU residents’ personal data, giving data subjects control over their information.
HIPAA Compliant
HIPAA compliance
Certified to the highest standards
We are certified according to industry-leading standards, providing highest levels compliance, safety, performance, and security.
EU MDR
2017/745 CE Class IIb EU Medical Device Certification
ISO 13485
Medical Device Quality Management System and basis for U.S. FDA QSR
MDSAP
Medical Device Single Audit Program (MDSAP) Certification
MHRA
Registered as a Class II(b) Medical Device with MHRA
ISO 27001
Information Security Management System
HIPAA
HIPAA ensures the protection of protected health information (PHI)
SOC 2 Type II
SOC 2 standards ensures secure data handling
IEC/ISO 62304
Software Life Cycle Process
IEC 82304-1
Health Software - Part 1: General requirements for product safety
ISO 14971
Risk Management Standard for Medical Devices
ISO 14155
Clinical investigation of medical devices for human subjects
IEC 62366
Usability Engineering Standard for Medical Devices
IEC 80001
Risk management for IT-networks incorporating medical devices
Regulatory intelligence
Monitoring of global regulatory requirements
FDA Approval
US Food and Drug Administration Medical Device
CyberEssentials
United Kingdom certification scheme for protection in cyber security
