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ISO 13485:2016

Medical device quality management system policy

Lutech S.p.A. provides products in the in-vitro diagnostic (IVD) medical device sector, both across Italy and internationally, with particular reference to middleware. It focuses on customers requiring dedicated products and customization.

The company’s development of new products and services aims to meet market requirements through its organization structured for development, management, manufacturing, monitoring, distribution and customer support for IVD devices, with the goal of expanding its own areas of expertise in order to present an ever-broader market offering.

Lutech’s products are offered both to the Italian and international markets, and feature technologies which are progressively improved through the increase and improvement of performance and the application of ever-greater professional expertise.

Compliance of the products with applicable legislation and technical standards is a key priority for the company, which is also considered a cornerstone in product promotion as a competitive advantage in the market.

In structuring itself and setting out growth plans, Lutech has made its Quality Management System a benchmark for the company’s operational management and customer relationships, with a strong focus on managing the context, stakeholder expectations, risks and opportunities, in a relationship which places communication with all stakeholders at its center.

Corporate management supports the development of ever-more competitive products, at contained costs which are competitive both within Italy and internationally. This means focusing on developing and consolidating the company’s market position by improving customer satisfaction levels.

Research and development requires adequate resources in order to satisfy the ever-increasing needs of the market in compliance with applicable legislation and standards for the countries where the products are marketed.

The materials and components used must be selected to satisfy products requirements which meet the requirements of specific customers and the market as a whole. For this reason, suppliers are considered strategic partners and crucial to meeting quality goals.

Production capacity must be based on partnerships with suppliers able to share the company’s requirements, and on internal human resources with suitable levels of qualifications and professionalism to be able to systematically apply the provisions of the Quality Management System and the operating instructions, and to use efficient means and tools.

The company’s suppliers consist, above all, of partners which supply software services to its customers, and of hardware manufacturers.

In order to ensure constant and robust business growth, it is essential that the investments generate the necessary return, with the awareness of following a path which increasingly allows for effective responses to the market.

Investments in the development of new applications and new technologies aim predominantly at platform innovation, as well as of the available functions.

Lutech values its human resources, whose motivation and sharing of company policies is an essential element in Lutech’s success. Fully exploiting and enhancing the abilities of its employees is one of the company’s main goals.

Every individual within the company is jointly responsible for maintaining the effectiveness of the QMS, within the roles assigned to them and the processes they are involved in, and in accordance with the purposes outlined in this policy.

Lutech pursues the satisfaction of its clients’ goals as a core value, in the awareness that only through continuous improvement is it possible to gain customer loyalty and guarantee growth.