Regulatory Compliance

Class IIa - EU MDR CE Mark

Medical Device Regulation
‍
Willem™ ECG Analysis Platform is certified as a Class IIa Medical Device under the EU Medical Device Regulation (MDR) 2017/745, ensuring compliance with rigorous safety and performance requirements.

Ambulatory ECG devices, including holter and patch
(1 and 2-lead)

Standard diagnostic resting ECG devices
(12-lead)

Insertable Cardiac Monitors (ICM)

CE marked - Class IIa
(EU MDR)

Information Security

Our compliance with leading international standards ensures robust security, privacy, and ethical business practices.

ISO 27001

Information Security Management System (ISMS) for structured data protection.

ISO 27017

Security controls for cloud-based services.

ISO 27018

Protection of Personally Identifiable Information (PII) in cloud environments.

ISO 27701

Privacy Information Management System (PIMS) for GDPR compliance, extending ISO 27001.

ISO 37001

Anti-Bribery Management System (ABMS) to ensure ethical business conduct and regulatory compliance.

IEC 81001

Cybersecurity framework for medical software, protecting against vulnerabilities, cyber threats, and unauthorized access.

DTAC Certified

The Willem™ ECG Analysis Platform meets the NHS Digital Technology Assessment Criteria (DTAC) for quality, safety, interoperability, and clinical effectiveness.

Data Protection

We adhere to European and national regulations for data protection:

GDPR (General Data Protection Regulation)

Ensures lawful processing of personal data in compliance with strict European privacy standards.

Spanish LOPD-GDD (Ley Orgánica de Protección de Datos y Garantía de los Derechos Digitales)

Regulates the processing and protection of personal data under Spanish law.

Spanish National Security Scheme (ENS)

Guarantees multi-layered security and compliance with national cybersecurity regulations.

If you’d like more information about our security and privacy policies, or to request our certifications, feel free to contact us