Regulatory

POST MARKETING SURVEILLANCE

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.

REGULATORY DOCUMENTS

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

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Download CE Certificate SQS TEKTONA®

CUSTOMER COMPLAINTS

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

CORPORATE GOVERNANCE AND STANDARDS

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.

UK modern slavery act compliance and anti-slavery statement central register
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Download our Modern Slavery Statement

Download our Corporate Social Responsibility Policy

PATIENT INFORMATION LEAFLET (FOR AUSTRALIA)

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.

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