Design and implementation of Quality Systems in compliance with the requirements of the ISO 9000 and EN 13485.
Definition and application of business training and education programs. The training programs can be carried out in collaboration with external organizations in charge of coordinating the vocation training activities or inserted in long-term projects, such as consulting activities, for example, for the definition and creation of a corporate Quality System in conformity with the requirements of the ISO 9000 and EN 13485 series standards.
Design and implementation of environment management systems compliant with the prescriptions of ISO 14001 standards and of corporate safety plans.
Design of electronic control instruments, apparatus and systems and of medical devices in compliance with the requirements of the Directives on Machinery, Medical Devices and In Vitro Diagnostics Medical Devices, Electromagnetic Compatibility, Low Voltage, Gas Appliances.
Consulting in the product and process certification sectors in compliance with the requirements of the EC Directives:
93/42/CE (Medical devices)
90/358/CE (Active implantable medical devices);
98/79/CE (In Vitro diagnostics medical devices);
93/43/CE (HACCP systems for food hygiene regulations);
89/392/CEE and subsequent amendments (Machinery);
90/396/CEE (Appliances burning gaseous fuels);
89/336/CEE and 92/31/CEE (EMC Electromagnetic compatibility).
Relevant technical activities
System design for battery charger for charge-controlled traction shunters;
Project design for wall-mounted heater compliant with UNI-CIG 7271 and 9893 and CEI 61-50 standards in compliance with Law No. 1083 dated 6/12/71 and with Law No. 46 dated 5/03/90 (Regulations for Installation safety), as well as with Law No. 10 dated 9/1/91 (Regulations for the containment of energy consumption). The heater obtained CE marking as granted by Gastec No. 161009 (see PIN CODE 63AR4009);
Electromagnetic compatibility tests on extracorporeal dialysis equipment and on power distributors pursuant to the Directives on Electromagnetic Compatibility 89/336/EEC and 92/31/EEC;
Project designs for medical devices for anaesthesia, Resuscitation and assisted pulmonary ventilation, including a CPAP pulmonary ventilation system bearing CE marking pursuant to Directive 93/42/EEC;
Project designs for heating and treatment systems for liquids, based on microwave technology;
Project design of gas measurement systems;
Project designs for heat/humidity exchangers for ventilation (patented);
Project design for paediatric and neonatal therapy NO distribution valve;
Project design for jet generator for CPAP (patented).