Our commitment to quality and safety is reflected in the international standards we follow. Below you will find an overview of our certificates, which demonstrate our dedication to delivering reliable and durable solutions that meet the highest demands in the industry.
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European Medical Device Regulation (MDR)
Cambios’ medical health record system COSMIC and the Clinical Decision Support (CDS) are registered and certified according to the MDR, Medical Device Regulation. This means that the products are approved and CE-marked according to the EU regulation on medical devices, which ensures the safety and performance of medical devices.
View the certificate via the link below.
What is European Medical Device Regulation (MDR)?
The European Medical Device Regulation is a European regulation for medical devices. The purpose is, among other things, to create a clearer regulation of software products to ensure that the medical technical services and products used in healthcare are safe and appropriate.
The MDR tightens the responsibility that manufacturers of medical devices have to document the product’s functionality, risks, and clinical performance. Certification according to the MDR is mandatory for all medical devices released on the European market since May 2021.
ISO Certificate
Cambio Group has a management system that includes quality, environment, information security and management of services and we are certified according to:
ISO 2000
This standard focuses on IT service management and ensures that an organization delivers IT services in an efficient manner that meets both business and customer requirements. It is adapted to ITIL and acts as a quality gauge for IT services.
Open certificate
ISO 27001
This standard deals with information security and provides a framework for managing and protecting sensitive information through risk management, policies and controls.
Open certificate
ISO 9001
This is a quality management system standard that ensures an organization consistently delivers products and services that meet customer and regulatory requirements, with a focus on continuous improvement and customer satisfaction.
Open certificate
ISO 14001
This standard relates to environmental management systems and helps organizations improve their environmental performance by reducing waste, streamlining resource use and complying with environmental legislation.
Open certificate
ISO 13485
This certification is specific to medical devices and relates to quality management systems for the design, manufacture and distribution of medical devices, ensuring that they meet regulatory requirements and maintain a high level of quality.
Open certificate