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  • We test more

    than just implants

  • The newest test methods

    specifically developed for your implants

  • Your competent partner

    for medical device testing

  • Mechanical Testing and Analysis

    from a single source

CUSTOMER-ORIENTED TESTING OF SPINAL IMPLANTS
Depending on your needs, we test your spinal implants during the development phase or for approval according to ASTM- or ISO standards - or following custom testing procedures adapted to the specific requirements of your medical device.
COST-EFFICIENT TESTING OF JOINT REPLACEMENT IMPLANTS
Our portfolio includes mechanical testings for joint replacement implants such as hip prostheses, knee prostheses or shoulder prostheses. They are examined for their mechanical performance in strength, fatigue and wear tests.
EFFICIENT AND SCIENTIFICALLY BASED PLANNING OF TESTINGS
In addition to the requirements of the MDR and FDA, it is above all the Notified Bodies that represent a major hurdle in the approval process for implants. Our profounded know-how and many years of experience make us your competent partner in the complex field of the approval of your implants and medical devices.

Welcome to SpineServ

SpineServ is your competent, interdisciplinary and accredited mechanical test facility for orthopaedic and dental implants, implant materials, surgical instruments and other medical devices such as syringes, cannulae or connectors.

We test your implants during the development phase or for approval according to ASTM- or ISO standards - or following custom testing procedures adapted to the specific requirements of your medical device.

With our profounded know-how and many years of experience Spineserv is your competent partner in the complex field of the approval of your implants and medical devices- We support you in the preparation of Technical Documentation according to EU-MDR and for the approval by the US FDA. Within the framework of the presentation of the Clinical Performance of your implant, we carry out Clinical Evaluations according to MEDDEV 2.7/1 Rev. 4 and build a complete chain of arguments - loading in vivo, acceptance criteria, validation and verification, worst-case selection - to demonstrate the Mechanical Safety of your implant and medical device.

Static and dynamic implant and medical device testing procedures

We offer static and dynamic testing for:

 

Connection to University Research

The close connection to university research guarantees consideration of the most recent scientific knowledge for medical device testing.

Know-how

SpineServ offers interdisciplinary expertise to address biomechanical, biological, and medical questions. This expertise is also available for scientific consulting and expert opinions.

Accreditation DAkkS

SpineServ GmbH & Co. KG is accredited according to DIN EN ISO/IEC 17025:2018, which is an accreditation accepted by the FDA.

Accreditation A2LA - Mechanical Testing

SpineServ GmbH & Co. KG is additionally accredited by the American accreditor A2LA according to ISO/IEC 17025:2017.

  • accreditation certificate and scope of accreditation (PDF-Download)