Quality System

    Fe.Ma applies, for the management of its activities, a set of management and operating procedures in accordance with the guidelines provided by the EC , through the procedure of the European Quality Promotion, covering the essential requirements that the organizational structure of a producer must possess in order to ensure the conformity of the products to the requirements.

    These requirements, specified in Directive 93/42/EEC about Medical Devices, have been incorporated by the State with Italian Legislative Decree 46/97 of 24/02/97 and subsequent amendments.

    The Fe.Ma Quality System has therefore obtained from Notified Authority "Cermet" the following certifications:

• MEDICAL DEVICE DIRECTIVE 93/42/CE
• UNI EN ISO 9001:2008
• UNI EN ISO 13485:2012

    These certifications enable the company to qualify as a manufacturer and supplier of "Surgical Disposable Sterile Set" CE marked and labeled with their own brand.

    In addition, periodic checks carried out by the Notified Certification Authority ensure the continuity of the adequacy of the organization and its processes to the standards listed above.

The Fe.Ma Quality System ensures also:

• staff training
• process control
• the computer system for the management and control of the process
• the identification and treatment of non-compliant products
• actions to prevent and to correct situations of non-compliance
• internal audits
• the selection and monitoring of suppliers
• the registration documentation and support

    Therefore, Fe.Ma is on the market with the greatest guarantee of professionalism, competence and competitiveness in the specific sectors of activity in which it operates.