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Quality, safety and management system certification

Quality and product safety are key priorities of the company. It is mainly based on the requirements of the International Standard ISO 13485 Medical devices – Quality management systems.

Safety of products by MEDIN, a.s. is provided in accordance with the European Directive 93/42/EEC, Medical Devices. Compliance with the requirements of this Directive is marked with the CE mark on products.

The management system established according to these International Standards represents the respected standard that supports credibility of the supplier in Europe as well as in the world.

Product safety

  • according to the Council Directive 93/42/EHS
  • according to the Law No.123/2000 Sb.
  • according to the Government Act No.336/2004 Sb.
  • as amended

Safety and suitability of the medical devices for medical care providing comply with the above mentioned statutory instruments. The products are marked with the CE Conformity symbol. Authorised person (the Notified Body) No. 0434 Det Norske Veritas participates in the medical device safety judgement according to the European Standard Directive 93/42/EHS. The Conformity declaration is issued for each individual product group.

Valid certificates:

  • ISO 13485 – quality of medical devices
  • ISO 9001 – quality management
  • CE – Sterile and Non Sterile Medical Devices
  • ISO 14001 – environmental protection

Eco-design

Eco-design is based on the systematic application of environmental requirements in our company. When developing new products, we strive to minimise the negative impact of the product and also the production process on the environment and achieve maximum savings at the same time. This way we ensure environmental compatibility for every product, from its development to final disposal.

Environmental profile

Company MEDIN, a.s. is aware of the fact that it influences the environment by its activity. Therefore the further development of the company is based of the principle of mutual relation between the economic growth and the environment.

A way how to realize this matter is set by environmental policy that declares a permanent and considerate behavior of the company to the environment.

Aspects register and aim

One of the initial materials for environmental policy determination is the register of environmental aspects that is continuously updated and analyzed. Particular environmental aims are defined within management control and they are mainly focused on permanent intentions of the environmental policy.

Permanent rules

When using environmental policy, MEDIN, a.s. is focused on fulfilling of the following rules:

  • To ensure the environment protection in all its activities in compliance with valid legislation. To consider the care about the environment as a part to of the company’s management. To perform the control activities by internal audits that ensure fulfilling of the set rules at all organization parts of the company included in the integral management system.
  • To prefer new procedures and new technology equipment. To minimize consumption of energy and raw materials by their effective using and to reduce environment pollution permanently and minimize the incidence of emergency conditions.
  • To consider the environment protection as an area of constant improvement where the prevention is the best solution rather than any other subsequent action.
  • The employees have their responsibilities and competences in relation with the environment and they are obliged to follow all the rules in order to minimize the incidence of emergency conditions. The employees are regularly educated in compliance with set procedures. Systematic training and education of the employees is understood as one of the ways leading towards the risks minimization connected with environmental danger.
  • To communicate openly with government offices, customers, suppliers, employees and the public, to exchange true and verified information that concern the environment protection. To choose the suppliers carefully that provide services influencing the quality and to perform the EMS according to set criterions and to control its qualification continuously. The projects from the designers and subcontractors must be in compliance with the permanent rules of the environmental profile.

Monitoring, improving

The company has developed procedures for a set monitoring and measuring. Among main monitored numbers belong: the consumption of energy, water, production of sewage water and waste treatment.

The company management is completely identified with the rules mentioned in this environmental profile and it is obliged to set up the conditions permanently and to ensure necessary sources for its fulfillment.

Company MEDIN, a.s. is hereby obliged to judge the environmental profile regularly with the help of suitably chosen indicators.