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Our ISO 13485 services:

  • Implementation of ISO 13485

Everything is here for the best price!


We establish “paperless” systems and offer free-of-charge FTP-site and cloud services, which are easily available via internet!

About ISO 13485 – Quality Management Systems for Medical Devices

Regarding medical devices, there is no standard that better represents the requirements for a comprehensive management system than ISO 13485:2003. Compliance with ISO 13485:2003 is often seen as the first step in achieving compliance with regulatory requirements. Medical device manufacturers who are placing their products on the market within the European Union will need to address compliance with the requirements of the applicable Medical Device Directive and the CE marking process. ISO 13485 is recognized as an aid in supporting compliance with the MDD.

The implementation of ISO 13485 is beneficial for those, who would like to:

  • be obliged to procedures for proving adequateness.
  • participate in public procurements.
  • have PR goals.
  • achieve a more efficient authorization and realization of the products.
  • reduce the number of the supplier’s audits.


Why you choose us for the implementation of ISO 13485?

Because:

  • our ISO 13485 advisor is one of the most recognized experts in Hungary,
  • we provide the latest legal frameworks,
  • we are applying the latest and easiest methodology,
  • we establish “paperless” systems working with e-forms,
  • as bonus we offer free-of-charge FTP-site and cloud services, which are easily available via internet,
  • we can establish systems also in English or in German.
  • we provide registered certifications, involving highly competent auditors.

 

 

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