SpineServ offers specialised testing and development services for implants and medical products

We stand for precise mechanical testing and specialised engineering services for implants and medical devices. Since 2007, we have been supporting manufacturers in getting products approved safely and in compliance with standards – with tests in accordance with ASTM, ISO and DIN standards, customised test setups and state-of-the-art measurement technology. Load, durability and functional tests form the centrepiece of our work and provide reliable data for regulatory procedures and development decisions.

With dual accreditation in accordance with DIN EN ISO/IEC 17025:2018 (DAkkS) and ISO 17025:2017 (A2LA), we cover a broad, internationally recognised testing portfolio. Our interdisciplinary teams combine technical understanding with medical expertise and develop test methods that precisely map complex product properties.

We also provide support with test planning, evaluation and the creation of biomechanical documentation. Further analysis methods such as ageing tests, optical 3D measurement technology and high-resolution microscopy enable detailed failure analyses. The result is an end-to-end testing process that guarantees safe, efficient and regulatory-compliant product evaluations.

Our focuses

Accredited mechanical testing of implants and medical devices

We test implants and medical devices for resilience, durability and mechanical performance – during development or for approval in accordance with ASTM, ISO and DIN standards. For complex requirements, we also develop customised test setups that are precisely tailored to product properties and customer needs.

Regulatory affairs and authorisation support

Mechanical safety and clinical performance are key requirements for market authorisation. We provide support in test planning, analysing the results and preparing technical documentation. Scientifically sound literature research and structured evidence facilitate regulatory procedures and strengthen development decisions.

Quality and dual accreditation

With accreditations in accordance with DIN EN ISO/IEC 17025:2018 (DAkkS) and ISO 17025:2017 (A2LA), we ensure a broad, qualified testing portfolio. The continuously expanding scope of accreditation guarantees reliable results for development, planning and product launch – with the highest standards of quality and safety.

Expertise and multidisciplinary approach

We combine science and technology: Thanks to our interdisciplinary teams, we understand both technical and medical aspects and develop test methods with a high level of validity. Our involvement in standardisation committees such as ASTM, DIN and ISO actively contributes to the further development of international standards.

Accompanying analysis procedures and human factor studies

Additional analysis methods such as ageing tests in climate chambers, 3D printing for customised solutions, optical 3D measurement technology and high-resolution microscopy support failure analyses and traceability. Human factors studies and use case analyses identify usage-related risks at an early stage and contribute to the development of safe, efficiently usable products.