Many medical devices employ porous coatings in order to stimulate better integration into the body. Ensuring these coatings conform to regulatory standards is critical to getting your product approved by FDA.
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Lucideon’s experts sit on a number of relevant committees including BS CH/150 Implants for Surgery and BS CH/150/SC1 Materials for Surgical Implants as well as ISO committees; TC 150 (Implants for Surgery), TC 150/SC1 (Materials for Surgical Implants), TC 150/SC1 WG3 (Materials for Surgical Implants – Ceramics) and TC 150 WG7 (Implants for Surgery – Coatings).
Lucideon has analyzed and evaluated numerous porous surfaces according to FDA guidelines, including plasma sprayed, sintered beads and additive manufactured surfaces.
We work routinely with metal (e.g. Ti), ceramic (e.g. hydroxyapatite - HA) and polymer (e.g. PEEK) coatings, for both regulatory submissions and quality control. Some of our most popular tests include:
- Coating thickness
- Surface roughness
- Porosity (including size and shape)
- Solubility product
- Adhesive/cohesive strength
- Particle or grain size / morphology
- Chemical composition / ratio
- Oxide content / oxidative state
- Residual particulate analysis.
Our people are also experienced in sample preparation, sectioning, mounting, polishing and etching where necessary, to provide high quality data.