Quality Management System

Medica operates according to a Quality Management System (QMS) which was created on the basis of requirements of the following Standards and Regulations:

  • ISO 9001:2015;

  • ISO 13485:2016;

  • EC CERTIFICATE;

  • MDD 93/42/EC about Medical Devices, introduced in Italy with DLgs (Legislative Decree) n° 46/97 and subsequent amendments / integrations

  • CODE OF FEDERAL REGULATIONS - TITLE 21- PART 820: QUALITY SYSTEM REGULATION


The main target of Medica Group is the full satisfaction of its customers, obtained through continuous and careful analysis of the market requirements and expectations, along with the best economic profit for the Company.
 
For this reason, the Management aims at continuous improvement of its organization and its staff.
 
The main guiding principles in Medica Group actions are:
 
  • constant training of personnel and its involvement in all the phases of Quality System implementation;
  • analysis of all the manufacturing processes for the continuous improvement and achievement of quality objectives for Medica Group products, in order to obtain the maximum level of safety and effectiveness for patients and users;
  • reinforcement of relationship with the customers;
  • search on the markets for new ideas and products.