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Implant Testing

Accredited Mechanical Implant Testing Services

We offer a wide range of relevant implant testing procedures for:

the spine

the hip

the knee

the shoulder

further total joint replacement

osteosynthesis

dental applications

implant materials

surgical instruments

 

Our testing procedures include:

  • static testing (stiffness, strength, etc.)
  • dynamic testing (fatigue)
  • wear testing
  • corrosion testing
  • testing according to national and international standars (ASTM, ISO – the standard testing procedures can be found on the subpages of our website)
  • testing according to custom testing procedures
  • testing during the development process
  • or testing for approval through the U.S. FDA, the European Notified Bodies (CE-Mark) or any other national authority

 

 

Improved quality and safety through latest test methods and supportive technologies

During the last few years we put much efforts in further increasing the quality and traceability of testing as well as on improving our time-efficiency. As accuracy and reliability are paramount to product safety, we use supportive technology such as Climate Chambers in various sizes for preconditioning and accelarated ageing, 3D - Printer for customized, individual solutions and reproducable test conditions,  or High Resolution Microscope for microscopic signs of failure and supportive interpretation of test results

 

Improved Performance and Safety in everyday clinical use, taking into account Use Cases and Human Factors (Usability) Studies

The specifications of the standards regarding setup and performance of tests are very strict. Nevertheless, factors of various kinds can influence and affect the performance of the medical device. Such factors can be in the design of the device itself, but also in its interaction of the device with its user within an environment that simulates its real environment of use in all its variety (medical staff, patient). Based on our multidisciplinary background and our expert knowledge, we support you in identifying those factors that affect the safety and performance of your device in everyday clinical use and in deriving suitable testing procedures to cover these factors. In this way, application errors and their consequences can be minimized in the development process. In particular, the fulfillment of certain performance criteria of the medical device can be proven in the approval process without the need for time-consuming and cost-intensive clinical studies.

 

Accreditation

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