Our Company meets all the legislative/regulatory provisions that govern the distribution of medical devices and we are certified according to the international standards EN ISO 9001: 2015 and EN ISO 13485:2016 regarding the inspection of the system for the observation of Principles and Guidelines of Good Distribution Practice in Medical Devices .
Our Company also holds Compliance Certificate for its Quality Assurance System, according to the Ministerial Decision No DY8d (Official Gazette No 32/16-01-2004) regarding the companies engaged in the distribution of medical devices.
In order to ensure the excellent quality at all levels of operation, our company :
- Has built a network information system which allows the monitoring, recording and filing of its responsibilities arising from the application of the above quality assurance systems. This information system enables us to trace all the materials traded by our company in terms of lot numbers and product codes.
- Supplies medical devices that meet the requirements of No 93/42 Directive of the European Union , i.e. certified according to EU requirements (CE marking of medical devices, and only from firms that are certified according to EN ISO 9001 & 13485 Standards.ISO 9001:2015 (pdf) – ISO 13485:2016 (pdf)
- Records responsibly all complaints, recommendations, or suggestions made by customers and proceeds with the required action in order to achieve full satisfaction of customer needs.
- Determines and possesses the required means, both in terms of infrastructure and human resources. Our personnel is suitable to perform the tasks assigned to them, trained according to the training program and assessed on an annual basis by an assigned Quality Supervisor. Our salespeople attend medical congresses on the company’s products, seminars of the manufacturing firms, and workshops.
- Has planned and implemented procedures of monitoring, analysis and improvement. Throughout the year, the company monitors the performance of the Quality Assurance System in terms of the goals set for review by the company’s management.
Company possesses and maintains the required infrastructure for the accomplishment of its goals and manages its working settings so as to ensure product quality and personnel’s health and safety.