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Quality System

Quality means to Tipromed s.r.l. carring out all activities in order to fully meet the implicit and explicit needs of Customers, Users and Patients, in compliance with laws and regulations in force.
Tipromed s.r.l. has thus implemented and maintained a Quality System certified according to UNI CEI EN IS0 13485:2012, implying closely monitoring and continuously improving the quality of manufactured products and offered services to its customers.

Product Quality

Tipromed s.r.l. keeps its products' quality in mind starting from their design. The materials used for manufacturing, performance, aesthetics and impact that the device will have during use and disposal are considered and carefully evaluated according to a predefined Risk Management plan, with the identification of critical points, the changes to be put in place for their resolution and tests to be performed to consistently ensure products’ quality.
All products manufactured by Tipromed s.r.l. are CE certified according to Dir. 93-42 EEC and as amended, satisfy the applicable requirements and technical standards and, if such conditions do not exist or new conditions the product must meet are established , the company will arrange specific internal control methods and instruments necessary for their implementation.
Once a product is created, the internal Quality Control , applies the planned Quality controls called for with the design to maintain rigid control of raw materials' quality and the manufacturing process as a whole until the release of the devices for sale.
product's packaging, control methods, contamination controlled environment, where the manufacturing and sterilization processes are performed, are all validated according to the applicable reference standards. Such validations are performed at predetermined intervals, or for the implementation of changes to the product.
Other services performed by third parties and that may have impacts on the quality of the products, such as transportation and final distribution, are kept under control in order to ensure that the User receives a product suitable for its intended use.
Finally, with regard to after-sales, factors such as customer satisfaction, any complaints, feedback provided by sales and accidents caused by equivalent products are regularly analyzed and tracked in databases. This allows Tipromed to stay ahead and ensure more effective responses to market needs.

Quality of Services

Tipromed s.r.l. offers its Clients many services, the most common ones are listed here:

  • TRAINING: Tipromed s.r.l. trains its customers, whether Distributors or End-users, offering special courses focusing on the criteria for the use of the devices in total safety. This allows accidents possibly damaging patients and operators to be avoided or minimized.
  • ASSISTANCE to Customers: Tipromed provides the experience of its competent technicians to help solve any problems that may arise under certain conditions and that the customer is unable to cope with.
  • REACTIVITY: Thanks to the presence of technical staff with decades of experience in the biomedical industry, Tipromed can respond promptly to market needs, adapting its products to the continuous evolution of standards, technical innovation and fields of application of manufactured devices.
  • PUNCTUALITY: One of Tipromed's priorities is respecting the delivery terms established with customers, We do not only effectively manage the supply of individual orders, but we promote, in close contact with the customer, more effective planning of orders themselves as well as production.

CUSTOMER SATISFACTION: In order to constantly improve its products and services, Tipromed regularly evaluates customers’ satisfaction through specific questionnaires.
Certificazione ISS
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