Regulatory
Regulatory
Regulatory
Regulatory
Regulatory
PMcardio's certifications

Certified AI-powered diagnostics and treatment

Certified technology

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.

Regulatory

Certified Medical Device
Manufacturer​

Regulatory

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.

Regulatory
Regulatory

Class II(b) EU MDR CE-mark​

Regulatory

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.

Regulatory
Regulatory

GDPR Compliant ​

Regulatory

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.

Regulatory
Certifications and standards

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

FDA Approval

US Food and Drug Administration Medical Device

In progress

CyberEssentials

United Kingdom certification 
scheme for protection 
in cyber security

In progress

Stay on the pulse with our newsletter.

Your submission was successful