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2023/10/10

ISO 13485:2016

We are pleased to announce that our company AVEDO S.A. was also certified with ISO 13485:2016 in October ΄23 by TUV AUSTRIA.
The certificate was awarded for the implementation of the quality management system for medical technology devices and products in accordance with the above standard in the field of "manufacturing non-sterile examination gloves".

The benefits of ISO 13485:2016

  • Ensures the company's compliance with the requirements of the applicable national and European legislation for medical technology products.
  • Enhances user and consumer confidence that the medical device complies with the requirements of international, European and national standards, as well as with applicable European and national legislative and regulatory provisions
  • Recognition of the certification by all interested parties (users, consumers, manufacturers, authorized traders, importers, EOF distributors and the competent European authorities) in the international, European and national market.

Yours sincerely,

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