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  • Your compentent 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

WELCOME TO SPINESERV - 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-efficient and customer-oriented mechanical testing for all types of implants
Our portfolio includes a wide range of mechanical testing procedures for spinal, joint replacement, trauma and dental implants. We also perform tests for surgical instruments and implant materials. We test according to standards (ASTM, ISO, etc.) or develop individual solutions, adapted to the requirements of your medical devices - during development process or for approval by the U.S. FDA, the European Notified Bodies (CE mark) or other national authorities.
MEDICAL DEVICE TESTING - Quality and Safety through validated test methods and supporting technologies
From design to appoval we support you regarding the mechanical characterization of your medical device. Our portfolio includes static and dynamic testing, test plan development, validation and verification, ageing and preconditioning for connectors, syringes and needles, pre-filled syringes, neddle-based injection systems, catheter flowmeters and many more. We test according to standards (ISO, EN, DIN, etc.) and develop and validate customized individual solutions adapted to the requirements of your medical devices. As a DIN EN ISO/IEC accredited testing laboratory, quality and safety is the overriding priority.
REGULATORY AFFAIRS SERVICES - scientifically sound planning and testing from a single source
Mechanical Safety and Clinical Performance are among the basic requirements that a medical device must meet for successful approval. We support you in the preparation of Technical Documentation according to EU-MDR and for approval by the US FDA. Within the framework of the Clinical Performance of your medical device, we carry out Clinical Evaluations according to MEDDEV 2.7/1 Rev. 4 and build a complete chain of arguments to demonstrate the mechanical safety of your medical device.

OUR SERVICE PORTFOLIO - Implants and Medical Devices

 

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

Implants and implant materials can be subjected to accompanying analytical procedures at SpineServ, such as optical surface and particle analysis

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)