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ISO 13485:2016

Medical device quality management system policy

Lutech proposes itself on the national and international market to provide products and services in the Medical Devices and in Vitro Diagnostic (IVD) sector, with particular reference to Middleware, and is oriented towards Customers who have needs that require dedicated products and customizations.

The development of new products and services is aimed at providing answers to the needs of the market through its organization structured for development, management, manufacturing, control, distribution and customer assistance for Medical Devices and IVDs, with the aim of expanding its own areas of expertise for an ever wider offer on the market.

Lutech products are intended for the national and international market, and are characterized by technologies that are progressively improved through the increase and improvement of performance and the application of ever better professional skills.

Compliance with current legislation, sector technical regulations and compliance with contractual requirements are a priority for the Company.
Compliance with current legislation and the technical regulations of the sector is also considered the basis in the promotion of the product as a factor of competitive advantage on the market.

Lutech has decided to structure and grow by considering the Quality Management System as a reference point for the operational management of the company and the relationship with customers with a strong focus on managing the context, the expectations of the Interested Parties, the risks and opportunities in a relationship that focuses on communication with all the Interested Parties. The Quality Management System is also a reference point for complying with the requirements of the EU 2017/745 and EU 2017/746 Regulations.

The Company Management supports the development of increasingly competitive products at low and competitive costs on the national and international market. This means focusing on the development and consolidation of the market position by improving the level of customer satisfaction.

Research and development activities must be equipped with adequate means in order to satisfy the ever growing needs of the market in compliance with the rules and legislation in force of the countries where the products are offered.

The materials and components used must be selected to meet the requirements of the products capable of responding to the needs of the market and customers. For this reason, Suppliers are considered strategic partners and essential elements for the achievement of quality objectives.

The ability to produce must be based on the collaboration of Suppliers able to share the Company's needs and on the internal professionalism of qualified personnel and able to systematically apply the provisions indicated in the procedures of the Quality Management System, in the operating instructions and using efficient means and equipment.
Suppliers are mainly represented by partners for the provision of software services to the customer and by hardware manufacturers.

To ensure constant and solid development for the company, it is essential that investments produce the necessary return in the awareness of following a path that increasingly allows them to provide effective responses to the market.
Investments in the development of new applications and new technologies are mainly oriented towards an innovation of the platform and available functions.

Lutech enhances the human resources available, whose motivation and sharing of company policies becomes an indispensable element for the success of the Company; the enhancement of the skills of collaborators is therefore one of the primary objectives of the company.

Each person in the company is called to participate in maintaining the effectiveness of the Quality Management System, in the functions assigned to him and in the processes in which he is involved, according to the purposes expressed in this policy.

Lutech pursues the satisfaction of customers' expectations as a primary value, in the awareness that only by constantly improving can customer loyalty be achieved and the development of its business is ensured.

Rivalta di Torino, January 04, 2022