- Implant Testing
- Medical Device Testing
- Regulatory Affairs
- About SpineServ
- Contact us
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.
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.
SpineServ offers interdisciplinary expertise to address biomechanical, biological, and medical questions. This expertise is also available for scientific consulting and expert opinions.
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.