Certification

We manufacture devices to the highest quality and safety standards. We undergo routine inspections so that our commitment in this area is recognized and certified by the relevant certification organizations. All our products meet the applicable requirements of EC Directive 93/42 and subsequent amendments and additions. Our manufacturing processes and quality system comply with UNI EN ISO 9001:2008 and UNI CEI EN ISO 13485:2012 in the field of design, production, sales and marketing of implantable medical devices for traumatology and orthopaedics and relative instruments.

Downloads the Certifications
Hip System CE certificate
Hip System EC Design Examination Certificate
Knee Prosthesis CE Certificate
Knee Prosthesis EC Design Examination Certificate
Shoulder CE Certificate
Shoulder Prosthesis EC Design Examination Certificate
Traumatology products and Instruments CE Certificate
ISO 13485-2016
ISO 9001-2015

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