(takes approx. 5 min)
To create a tailored test plan, please provide some information about your device.If you’re unsure about a question, just leave it blank.
This generator is free to use. Please note that it is supplementary to the expertise of an RA professional.We strongly recommend discussing the generated plan with your targeted regulatory authority before submission.
All information you provide will be used solely for generating your test plan and will not be shared with third parties. If you require an NDA beforehand, please reach out via the contact form.
Once complete, you will receive a copy of your responses along with the generated test plan by email
You can select multiple devices at once
Spinal Interbody FusionImplants that stabilise the spine by removing a degenerated intervertebral disc and replacing it with an implant placed between two vertebrae.
Posterior FixationImplants for stabilisation where screws, rods, or plates are implanted from the back (posterior approach) of the spine.
Motion-preserving ImplantsAs an alternative to fusion, these devices aim to maintain or restore natural spinal movement while relieving pain.
The manufacturing method influences the performance criteria that your submission needs to highlight. The intended spinal location determines the loading conditions that must be applied to your device.
Expandable cages need to meet the same general requirements as standard cages. In addition, tests of the expansion and locking mechanism will be necessary.
VBRs can be partially tested with methods for spinal cages, but do require additional attention and specialised setups.
Spinal bone plate testing is a mixture of standard osteosynthesis plate testing ans specialised spinal standards.
There is a standard set of tests that is carried out for pedicle screws. The are tested partially on their own and partially in combination with rods and other components of spinal constructs.
Spinal rods are typically relatively straightforward to test.
The point of interest on spinal hooks is usually the connection strength to the rod in various load directions.
The point of interest for spinal hooks is usually the connection strength to the rod in various load directions.
The point of interest for lateral connectors is usually the connection strength to the rod in various load directions.
Spinal Discs combine aspects of cage testing with those of wear testing.
Nucleus Replacements are an innovative field with no standard approach. We are well-equipped to create custom test setups to fit your design.
Facet Joint Replacements are an innovative field with no standard approach. We are well-equipped to create custom test setups to fit your design.
Interspineous Spacers are an innovative field with no standard approach. We are well-equipped to create custom test setups to fit your design.
Please let us know where you intend to market your device so we can take into account the specifics of the relevant approval processes.Our reports are accepted internationally and well-known by authorities like the FDA and PMDA.
