As of May 2020, the regulations on the use of medical devices changed and it is mandatory to use CE Class 2 certified software.
Do you meet the parameters imposed by the Medical Devices Act?
Is the software you currently use up to date with this new standard?
Do you have a technical partner that can meet all the quality certification requirements?
We can guarantee all this: trust Equipe!
Quality is essential to guarantee good care. Ensure solutions with a high degree of reliability!
The Equipe platform undergoes certification processes in accordance with internationally recognised quality management system standards. For each of the activities that involve the process of designing, developing, and delivering the application solution, we foresee an iterative process based on 4 fundamental steps:
Each activity is subject to continuous controls and reviews, aimed at obtaining quality and compliance with the standards that regulate the social and health sector.
Connect Informatics Srl is certified by Bureau Veritas in accordance with the UNI EN ISO 9001 and UNI CEI EN ISO 13485 standards, for:
The ISO 9001 Quality Management System standard guarantees the infrastructure, procedures, processes and resources necessary for companies to:
The ISO 13485 Medical Device Standard is an Internationally recognized Quality Management System (QMS) for Manufacturers of Medical Devices and associated services. The main objective of the standard is to establish a set of harmonised regulatory requirements for Quality Management Systems, within the Health Products Sector.
The ISO 27001 standard on the Quality Management System guarantees the infrastructure, procedures, processes and resources necessary for companies to:
In accordance with Directive 93/42/EEC and subsequent amendments, Equipe is a medical device classified in accordance with MEDDEV 2.1/6 July 2016, and is periodically registered in the ministerial list of medical devices (Ministry of Health. Registration n.576408 – first registration date 03-07-2012).
The Equipe solution and business processes have been assessed as compliant according to the SDP©10003:2015 scheme. The latter has been taken by ACCREDIA as the national reference standard, already accredited for the assessment of compliance with the new EU Reg. 2016/679. In particular, the principles of:
Privacy by design: to implement the principles of data protection and integrate the necessary guarantees for compliance with the Regulation into the processing.
Privacy by default: to ensure that only the personal data necessary (by default) is handled for each specific purpose of the processing.
The ENS is the Legislative framework that establishes and develops the security policy in the use of electronic media so that organisations belonging to the public sector and those belonging to the private sector that support, offer and provide secure services to citizens. This Regulation lays down the minimum and necessary conditions to ensure that citizens and public administrations can exercise their rights and fulfil their duties.