Coating Validation

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.

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. 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)
  • Crystallinity
  • Solubility product
  • Adhesive/cohesive strength
  • Particle or grain size / morphology
  • Chemical composition / ratio
  • (Micro)hardness
  • 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.

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Resources

  • White paper

    Additive Manufacturing - A Metallurgical Perspective

    pdf 4 MB

  • White paper

    The Use of Imaging for Claim Support in the Healthcare Industry

    pdf 6 MB

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  • Surface & Coating Analysis

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