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.
Certified Medical Device Manufacturer
Certified medical device manufacturer
Powerful Medical is certified to design, develop, and distribute software as a medical device for AI-powered diagnostics and treatment. With TÜV SÜD, we chose the globally leading organization for independent inspection and certification of the safety, quality, and performance of all our products and processes.
Class II(b) EU MDR CE-mark
Class II(b) EU MDR CE-mark
The PMcardio Platform is a certified class II(b) medical device according to the EU Medical Device Regulation (MDR) 2017/745, validated according to the highest requirements of risk management, clinical testing, technical performance and industry standards.
Our platform is independently certified by TÜV SÜD.
GDPR Compliant
GDPR compliant
As the GDPR is widely considered to be the most stringent global privacy standard, we have mapped our privacy program to the GDPR and other global privacy regulations. The EU General Data Protection Regulation (GDPR) is a comprehensive data protection law that governs the collection of and use of personal data of EU residents and allows data subjects to exercise control over their data.
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 MDSAP
MHRA
Registered as a Class II(b) Medical Device with MHRA
ISO 27001
Information Security Management System
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
510(k) Clearance
US Food and Drug Administration Medical Device 510(k)
CyberEssentials
United Kingdom certification scheme for protection in cyber security