Regulatory Submission Support
If you’re looking for support in gaining and keeping regulatory approval for your medical devices, Lucideon can help - whether you want to make sure that you’re doing the right tests, or whether you simply want a partner that you can trust to perform the testing to the highest quality.
We provide quality data and technical support with full documentation. In the heavily scrutinised 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, with expertise in chemical, physical, microstructural, microbiological and surface analysis, will ensure your medical devices are ready for regulatory submission. We have experience working with several regulatory authorities, including FDA, and we understand what is required.
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
- Establish and validate cleaning processes
- Characterise new materials for biocompatibility and benchmarking
- Full mechanical testing incl. fatigue
- Establish substantial equivalence
- Validate FEA models, by testing to failure or using our new 3D-strain service.
We will build a partnership with you, offering expert support and technical help should any problems occur with your device.