QUALITY CONTROL & CERTIFICATIONS

Production and quality, in addition to CE requirements

From the raw material to the finished, packaged product, every aspect of the production process is closely monitored, followed, and subject to strict checks at every single stage.

Random checks are performed using electroscopes and electron microscopes, meaning that even the tiniest of imperfections can be identified and quality standards can be maintained.

As such, all NSI supplies have been certified by ICIM (Italian Certification Institute for Mechanics) with the code CE 0425, as per existing European legislation.

Every NSI implant is protected by an insurance cover for up to a maximum value of €500,000.00. Download the mechanical testing document.

DECONTAMINATION AND STERILISATION

The decontamination and washing processes are carried out in controlled and sterile settings. Packaging takes place in an ISO 100.000 cleanroom and is followed by treatment with BETA rays. The external part of the package consists of a container bearing all the product data and a red toning stamp that guarantees the irradiation to which the product was subjected.

Inside, the blister, which is guaranteed against aging and for the sealing grip, as required by the regulations in force, repeats the same information and stamp, and is marked with a barcode. The sterile glass vials, which are the housing for the implant and its titanium mount, and the blister that contains them constitute double protection against contaminating agents.

In the package, there are two labels that the doctor will be able to append to the patient’s clinical record and to the NSI Implant Passport.

CERTIFICATIONS

The precise, thorough procedures implemented at our establishment guarantee the total integrity of our products.

Every process takes place in a controlled, aseptic environment, from decontamination and washing to packaging carried out in an ISO 5 cleanroom.

certificazione cermet prove meccaniche impianti NSI

Mechanical tests of NSI PLANTS performed at ICIM CE 0571 laboratories

Microsoft Word - Report moncone 0° piegato

Mechanical tests of NSI SINGLE PHASE SYSTEMS performed at POLITECNICO DI MILANO 2019 laboratories according to FDA regulations.

Mechanical tests of NSI BIPHASIC SYSTEMS performed at POLITECNICO DI MILANO 2019 laboratories according to FDA regulations.

Instructions for use (2019)

certificato-icim-n.-0425-med-003136-00--approvazione-del-sistema-completo-di-garanzia-di-qualita

ICIM Certificate N. 0425-MED-003136-00 – Approval of the Complete Quality Assurance system

certificato-icim-n.-0425-med-003137-00--approvazione-del-sistema-completo-di-garanzia-di-qualita

ICIM Certificate N. 0425-MED-003137-00 – Approval of the Complete Quality Assurance system

ISO 13485:2021 Quality Management System Certificate

ISO 13485:2021 Quality Management System Certificate

OUR PATENTS

Authenticity is a fundamental principle and it is important for products to be protected. The implant market is a competitive one and NSI want to guarantee that their implants are original by filing patents.

NSI’s ultimate professionalism shines through in their inventions and exclusivity, guaranteeing that their products are both completely innovative and unique and so able to compete with the big names in the industry. Innovation, simplicity and originality: NSI s.r.l.’s top three priorities for their certified and patented products.

QUALITY CERTIFICATES REQUEST

I would like to receive the PDF documents for following Quality Certifications:
(1) Mechanical tests of NSI PLANTS performed at ICIM CE 0571 laboratories(2) Mechanical tests of NSI SINGLE PHASE SYSTEMS performed at POLITECNICO DI MILANO 2019 laboratories according to FDA regulations(3) Mechanical tests of NSI BIPHASIC SYSTEMS performed at POLITECNICO DI MILANO 2019 laboratories according to FDA regulations(4) Instructions for use (2019)(5) ICIM Certificate N. 0425-MED-003136-00 – Approval of the Complete Quality Assurance system(6) ICIM Certificate N. 0425-MED-003137-00 – Approval of the Complete Quality Assurance system(7) ISO 13485: 2012 Quality Management System Certificate

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