ISO 13485 Certification

In 2024, Eumaco achieved ISO 13485 certification, the internationally recognized standard for quality management systems for medical devices.

Compliance with this standard means placing quality at the heart of every process—from internal operations and product design to customer satisfaction.

This achievement reflects our ongoing commitment to safety, reliability, and regulatory compliance—core values that guide everything we do.

The New Oyster and the Launch of STEPP

Through close collaboration with physicians and nursing staff, we developed the latest version of our telemedicine data management platform: Oyster ECG & More.

Today, Oyster seamlessly integrates both cardiac telemonitoring and multiparameter remote monitoring data into a single platform. The software has been completely redesigned to provide an even more intuitive, efficient, and secure way to manage medical devices, data transmissions, patients, and telemonitoring personnel.

As a certified medical device, Oyster ensures that patient data is encrypted and transmitted securely, meeting the highest standards of data protection and reliability.

We have taken telemedicine a step further by expanding our portfolio with STEPP, our new multiparameter home telemonitoring system.

STEPP is a range of advanced medical devices fully integrated with Oyster. Thanks to its wide range of compatible peripherals, it enables healthcare professionals to remotely monitor, record, and compare clinical parameters over time, including:

• Oxygen saturation (SpO₂)
• Body temperature
• ECG
• Blood pressure
• Body weight
• INR
• Bioimpedance

Designed to be simple, flexible, and customizable, STEPP provides physicians with detailed, clinically relevant information tailored to each patient’s monitoring needs.

Early Successes and the Launch of Oyster ECG Manager

Building on years of experience and the valuable feedback of leading Key Opinion Leaders (KOLs) and healthcare professionals, we developed Oyster ECG Manager, our web-based telemedicine platform for managing remote ECG monitoring.

The platform enables specialists to review and manage ECG recordings transmitted remotely by patients using our monitoring devices. Driven by our commitment to continuous innovation, Oyster ECG Manager has been consistently enhanced and refined, evolving into a trusted solution that is now used internationally.

In the same year, thanks to our collaboration with some of Italy’s leading cardiology and cardiac surgery departments, we launched pioneering home telemonitoring projects for patients with heart failure. These initiatives marked an important milestone in the development of remote patient care, demonstrating the clinical value of telemedicine in supporting the long-term management of chronic cardiovascular conditions.

A Year of Transformation

2006 marked a turning point for Eumaco. It was the year our management team made the strategic decision to specialize in telemedicine, a field widely recognized as one of the most promising frontiers of modern healthcare.

Driven by the rapid advancement of mobile technologies, including tablets and smartphones, telemedicine has transformed the way many medical conditions are diagnosed and managed, reshaping healthcare delivery and expanding access to quality care.

Our decision to focus our expertise and resources on such an innovative sector was made possible through a strategic partnership with a global leader in telemedicine, whose experience and vision helped accelerate our growth and development.

The Birth of Eumaco

Eumaco was founded within the S.O.S.A. Group as an engineering-focused business unit, with the mission of identifying, developing, and introducing the latest technological innovations from the European market to Italy.

The name Eumaco is both a company acronym and a combination of the Greek words Eu (“good” or “positive”) and Makhos (“determination” or “striving”). Together, they reflect the company’s identity: a young organization driven by innovation, positive impact, and the determination to compete with professionalism and excellence in the Italian market.

From the very beginning—and still today—Eumaco has worked alongside leading international companies in their respective fields of expertise. These long-standing partnerships provide a strong technical and commercial foundation, enabling us to respond effectively to market needs and deliver tailor-made solutions and value-added services designed around each customer’s specific requirements.