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.
FDA De Novo Authorization
Queen of Hearts™ (ACS AI ECG Module) has received De Novo authorization from the U.S. Food and Drug Administration, permitting its marketing in the United States.
Class II(b) EU MDR CE-mark
Certain AI ECG Modules within PMcardio are CE-marked as Class II(b) medical devices under EU MDR 2017/745, meeting the highest standards in risk management, clinical testing, and technical performance. They are independently certified by TÜV SÜD.
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 compliance
Powerful Medical is HIPAA compliant, ensuring that we adhere to the comprehensive regulatory framework required for safeguarding protected health information (PHI) in the United States.
Certified to the highest standards.
We are certified according to industry-leading standards, providing the highest levels of compliance, safety, performance, and security.
FDA De Novo Authorization
De Novo authorization for Queen of Hearts™ (ACS AI ECG Module) from the U.S. Food and Drug Administration
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 requirement
CyberEssentials
United Kingdom certification scheme for protection in cyber security
Explore our comprehensive security measures, compliance certifications, and real-time updates.
