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  • Your competent partner

    for accredited medical device testing

  • The newest test methods

    specifically developed for your implants

  • Mechanical testing and analysis

    from a single source

  • Quality and Safety

    our expertise for your requirements

++ Implant Testing Update: White Paper on Mechanical Testing of Spinal Implants – "Literature-Based Approach for Pre-Clinical Mechanical Testing of Spinal Implants" – in collaboration with TÜV SÜD + Download here ++

++ Implant Testing Update: White Paper on Mechanical Testing of Spinal Implants – "Literature-Based Approach for Pre-Clinical Mechanical Testing of Spinal Implants" – in collaboration with TÜV SÜD + Download here ++

WELCOME TO SPINESERV - Your Partner of Choice for Accredited Implant and Medical Device Testing Services

Since 2007 we are specialized on the mechanical testing of implants, medical devices, surgical instruments and implant materials. We test according to standards (ISO, EN, DIN, etc.) or develop and validate customized, individual solutions adapted to the requirements of your medical devices.

Our Know-How - Your Success - as one of the foundation pillars of our corporate philosophy clearly defines our mission to create the best conditions for safe and reliable test results through the interaction of science and technology.

Our Quality - Your Safety - SpineServ GmbH & Co. KG is a DIN EN ISO/IEC 17025 accredited testing laboratory. Maintaining and continuously developing our accreditation is one of our most important goals.

IMPLANT TESTING - cost-effincient and customer-oriented mechanical testing for all types of surgical implants
Our portfolio includes a wide range of mechanical testing procedures for spinal implants, joint replacements, osteosynthesis, and dental implants. In addition, we offer testing services for surgical instruments and implant materials. We conduct tests in compliance with ASTM, ISO, and other standards, or according to customized test methods, either as part of the development process or for regulatory approval by the US FDA, European Notified Bodies (CE marking), or other national authorities.
Medical Device Testing- Quality and Safety through validated test methods and supportive technologies
From development to approval, we support you in the mechanical characterization of your medical devices. Our portfolio includes static and dynamic testing in accordance with the latest standards, test plan development, (design) validation and verification, aging, and preconditioning. We conduct tests based on ISO, EN, DIN, and other standards. Depending on your needs, we also develop and validate customized solutions tailored to the specific requirements of your medical devices. As an accredited testing laboratory according to DIN EN ISO/IEC, we prioritize quality and safety at all times.
News: WHITE PAPER ON THE ISO 80369 SERIES - now available for download: Insights and Practical Solutions
In our White Paper "ISO 80369 Series of Standards – Pitfalls and Margins for Physical Testing", you will find everything you need to know about this standard series, with a special focus on mechanical testing and the associated challenges. The development of this comprehensive White Paper was inspired by numerous inquiries from our customers regarding the specific application of test methods and the related regulatory requirements.

OUR SERVICE PORTFOLIO

 

PRODUCT TYPES

 

 

 

TEST CATEGORIES

 

  • ASTM, ISO or other recognized standards

  • Customized solutions that specifically address your requirements

  • Static testing / Dynamic fatigue testing

  • Wear testing

  • Corrosion testing

  • Compression / Tension / Torsion / Multiaxial testing

  • Leakage / Flow / Kink / Drop testing

  • Testing during the development process

  • Testing for approval

  • Testing required for clinical complaint management

  • Supporting procedures: optical surface analysis, particle analysis, microscopy

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)