Certificates and compliance

Meeting the highest medical standards

Our commitment to overall compliance is present in every operational cornerstone by ensuring high-quality products and services, nourishing ethical business practices, and empowering transparent and supportive relationships with all stakeholders. We recognise that maintaining the trust and confidence of our stakeholders is paramount to our success, and we are dedicated to upholding the highest standards of integrity in everything we do.

Below, you can find our current valid certifications.

MDSAP

The Medical Device Single Audit Program (MDSAP) allows for a single regulatory audit of a medical device manufacturer’s quality management system to satisfy multiple jurisdictions.

ISO/IEC 27001:2022

Provides a framework for establishing, implementing, and maintaining an information security management system to protect sensitive data.

ISO 9001:2015

Sets out the criteria for a quality management system, focusing on consistent product quality and customer satisfaction.

ISO 13485:2016

Specifies requirements for a quality management system in the design and manufacture of medical devices, ensuring consistent quality and regulatory compliance.

ENS (Esquema Nacional de Seguridad) conformity certification badge, HIGH category, RD 311/2022

Certification of Compliance with the National Security Framework (ENS)

The Spanish National Security Framework defines cybersecurity requirements for protecting information systems, data and digital services.

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