We are aware of the software's influence on the safety and performance of medical devices.
For this reason, we guarantee absolute traceability for all distributed products, timely interventions in cases of suspected or claimed non-compliance and the necessary regulatory documentation to allow our customers to pursue the desired certifications.
We are ISO 13485 in progress.
The "ISO 13485 Medical Devices - Quality Management Systems - Requirements for regulatory purposes" is a standard pursuant to Directive 93/42 / EEC and subsequent amendments, concerning Medical Devices.
This certification is a guarantee, to customers and to the market, of product quality and safety thanks to the control of its development, the management of production activities and the prevention of risks during all stages of the manufacturing, storage and delivery process.
Being an ISO 13485 certified company demonstrates our commitment to want to provide customers with products and / or services aligned with the state of the legislative and regulatory art, through the application of tested organizational models aimed at improvement.
Our company is GDPR compliant.
The GDPR (General Data Protection Regulation) is a regulation through which the European Commission intends to strengthen the protection of personal data of EU citizens. The text became effective starting May 25, 2018.
The regulation also deals with the issue of exporting personal data outside the EU and obliges all data processing owners (including those with registered offices outside the European Union but processing data of residents in the European Union) to fulfill to obligations under the regulation.
As a company involved in the production of medical devices, we know that within the United States it is mandatory to proceed with the annual registration to the FDA and to appoint a US Agent.
In addition to the registration of the plant, the certification of the device to be exported is also required, the certification varies according to the classification that FDA assigns to the various devices, dividing the Medical Devices into increasing classes based on their complexity (Class I, II and III ).
The CE marking certifies that the product has been evaluated and meets the EU requirements for safety, health and environmental protection. It is valid for products made both inside and outside the European Economic Area (EEA) and marketed within its territory.
In order to affix the CE mark it is necessary to prepare a technical file that demonstrates that the product meets the EU requirements.
The HIPAA (Health Insurance Portability and Accountability Act) obliges organizations and health personnel to implement security and privacy measures that protect the confidentiality and integrity of identifiable and electronically transmitted health data (known as "protected health data").
Furthermore, as established by the HITECH standards (Health Information Technology for Economic and Clinical Health), HIPAA obliges healthcare organizations to require their "business partners" who have access to protected health data (PHI) to implement security measures and privacy provided by HIPAA.