Mia-Care is deeply committed to providing the highest quality standards on activities involving partners and clients. The expertise gained through the last years allowed the R&D Team to match technical excellence with certified processes and best practices enabling flawless and secure project delivery.

ISO 13485:2016

Design and development, production, installation, and maintenance of medical software, software for medical devices.

ISO 13485 ensures the ability to develop and deliver medical devices and software by meeting customer requirements and applicable regulatory requirements from the MDR. The main purpose of this standard is to facilitate the certification of digital solutions that communicate with harmonized medical devices for quality management systems.

Mia-Care is currently helping several companies to achieve certification for Software as a Medical Device by building new digital MDR-ready products with a compliant-by-design software suite.

ISO 27001:2017

Deployment and delivery of IT solutions for building Cloud Native platforms.

This certification represents the international standard that describes best practices for an Information Security Management System. Through this ISO, we demonstrate compliance concerning information security best practices and according to business objectives.

The company also received the related ISO 27017 and 27018 strengthening the attention given to information security. In particular, ISO/IEC 27017 is the reference for general security controls for cloud service users and providers, while ISO/IEC 27018 refers to controls for public cloud service providers acting as data controllers.

ISO 9001:2015

Design and development, production, installation, and maintenance of medical software, software for medical devices.

The ISO 9001 standard defines the minimum requirements an organization must meet to guarantee the claimed quality of the product and service provided. This certification is dedicated to the continuous and constant improvement of the company, optimizing the organizational structure and having the tools to make it more efficient over time, depending on the pace of growth.

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