Regulatory

We intend to facilitate the uniform application and implementation of our Post-Marketing Surveillance system.
The principal purpose of our surveillance is to insure that the health and safety of our patients and users is protected by reducing the likelihood of reoccurrence of the event. This will be achieved by the evaluation of reported events (refer to Customer Complaints), and, where appropriste appropriate, dissemination of information, which could be used to prevent such repetitions, or alleviate the consequences of such events.

At its inception, Spineart developed a Quality Management System, and continues to improve upon that system, based on applicable standards and regulatory rules.

Download ISO Certificate

Download CE Certificate KIWA

Download CE Certificate KIWA

Download CE Certificate SQS

Download CE Certificate SQS TEKTONA®

To assist device users, the following documents are available online:

• Surgical Techniques – Technical information provided by the manufacturer to inform the device user of the operating protocol. It is provided by the manufacturer to support and assist the device users in its safe and appropriate use.
• IFU – Instructions for Use are general and technical information provided by the manufacturer to inform the device user of the medical device’s intended purpose and proper use and of any contraindications, warnings, or precautions to be taken. It is provided by the manufacturer to support and assist the device users in its safe and appropriate use
• PIL – To assist with patient – doctor discussions prior to surgery, patient information leaflets are available online to help explain the type of medical device under consideration, including information on the medical condition the device has been designed to treat.
• SSCP – Intended to provide public access to an updated summary of clinical data and other information about the safety and clinical performance of the medical device, the SSCP is an important source of information for intended users – both healthcare professionals and if relevant for patients.

Request one of the above document

To allow our customers or whoever to communicate about events related to our products or services, a Customer Compliant Form is available to be fill in online. To allow our customers to communicate about events related to our products or services, a Customer Complaint Form is available online.

Download Customer Complaint Form

Our governance policy refers to our responsibility toward our environment. Our company’s existence is not lonely. It’s part of a bigger system of people, values, other organizations and nature.

Visit Tisc Report

Download our Modern Slavery Statement

Download our Corporate Social Responsibility Policy

To assist with patient – doctor discussions prior to surgery, patient information leaflets are available online to help explain the type of medical device under consideration, including information on the medical condition the device has been designed to treat.

Request a PIL