Kiwa Medical

Kiwa Medical

Ensuring excellence
Safeguarding people

Kiwa for the certification of medical devices

The topic about products’ safety is nowadays a priority acquired by any manufacturer: this issue is even more relevant for what concerns medical devices, which function is often critical, in order to guarantee the effectiveness of medical treatments. The delicate matter regarding safety applied to medical devices, makes it necessary to rely on expert partners that do have the capacity to activate a team which is provided with the necessary multidisciplinary competencies, in order to certificate the features of the products in question.

This takes place through the traditional employment of three specific tools:

  • Applied experience
  • In-depth knowledge of the regulations in effect
  • Competencies regarding the state of the art of technologies and processes

Kiwa has the ability to supply the tools for the conformity evaluation, according to what is set by the Directive 93/42/CEE and subsequent amendments or by optional technical regulations, being a Notified Body for the CE Mark and being qualified for certifications according to the international regulations ISO 9001 and ISO 13485.

Kiwa offers to manufacturers of medical devices a complete system and product certification, guaranteeing support during the entire development of the process, reducing duration, employment of resources and costs. Placed on the label of the product, the Kiwa certification and certification brand, which are acknowledged internationally, are an important communicational and promotional tool, which enhance the added value and the distinguishing factors offered by the certified product.

Besides the necessary certification activities, Kiwa also offers to manufacturers of products a number of opportunities which complete the service provided:

  • Laboratory tests (tests regarding electrical safety, electromagnetical compatibility, mechanical tests, chemical analysis etc.)
  • Voluntary product certification schemes which aim to increase the value of national production and seek its exportation, creating at the same time a sort of safeguard for the consumer, in order to prevent the spreading of products which are less reliable and technologically behind.