Regulatory Strategy & Testing - Orthopaedics
If you're looking for support in gaining and keeping regulatory approval for your orthopaedic devices, Lucideon can help - we perform a full range of complementary tests, method development and validation and support for regulatory documentation for a successful submission.
We provide data, interpretation and technical support throughout every stage of your product development, or just when you need us. In the heavily scrutinized area of medical device regulations it is reassuring to have experts on your side, who have prior experience of performing the tests.
Lucideon's ISO 17025 accredited laboratories, and expertise in chemical, physical, microstructural, microbiological and surface analysis, ensures your orthopaedic devices are ready for regulatory submission.
Some examples of what we can do:
- Develop and write the testing protocol for regulatory submissions
- Compare dossiers from one regulatory submission against the requirements of another
- Validate hydroxyapatite (HA) coatings against the FDA guidance
- Evaluation of porous metallic surfaces including additive manufacture
- Simulated wear testing of hips and knees
- Establishing and validating cleaning processes
- Characterization of new materials for biocompatibility and benchmarking
- Full mechanical testing including fatigue
- Establishing substantial equivalence
- Validation of FEA models, by testing to failure or using our new 3D-strain service.
Lucideon has worked with Greatbatch Medical to help them gain FDA approval.
Surface contamination investigation
Testing & analysis provided by Lucideon