CERTIFICATIONS
Digital Products Made in Quality
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 27001:2022
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 certification ISO 27001 was integrated by the controls required by guidelines ISO/IEC 27017:2015 and ISO/IEC 27018:2019, which extend the scope of ISO/IEC 27001 by providing specific controls and guidelines to ensure that information security and personal data protection within cloud services are guaranteed.
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.