Regulatory Compliance

AstraZeneca and Idoven launch CONCERTO to advance early amyloidosis diagnosis. Read more here.

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)

0051

CE marked - Class IIa
(EU MDR)

Class I - Willem Workspace

Medical Device Regulation
‍
Willem Workspace is self-certified as a Class I Medical Device under the EU Medical Device Regulation (MDR) 2017/745, ensuring compliance with rigorous safety and performance requirements.

CE marked - Class I
(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.

ISO 42001

Artificial Intelligence Management System (AIMS) for governing, managing, and ensuring the responsible, safe, and ethical use of AI within organizations.

ISO 13485

Quality Management System (QMS) for medical devices, ensuring consistent design, development, production, and regulatory compliance across the product lifecycle.

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

HDS Certification

Status:

Idoven is currently in the process of obtaining HDS certification in accordance with the French Public Health Code and the General Data Protection Regulation.

Once obtained, this section should include the certificate of conformity, its scope, issuing body, and validity dates.

1. Data Hosting Location

Health data is hosted within the European Economic Area (EEA) by Google Cloud.

2. Transfers Outside the EEA

Based on the information provided, no transfer of health data outside the EEA is performed.

3. Representation of Guarantees

In accordance with Chapter 8 of the HDS certification framework, the following table provides transparency regarding the actors involved in the processing of health data: