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Regulatory Strategy & Testing - Orthopaedic & Medical Implants

We provide regulatory testing and rationale support for the orthopaedics industry.  Our full range of complementary tests, method development and validation are designed to support OEMs in producing their regulatory documentation ready for successful 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.

Our experts have a depth and breadth of experience of the requirements demanded by the FDA.  If you are preparing for 510K submission then get in touch and discuss how we can support with third party testing, validation and troubleshooting.  We find that FDA standards are the most sought after tests for orthopaedic devices, but we also work to other standards when required by you.

Having the rationale, and not just the numbers, means you will be better prepared for any push backs from the FDA or other regulatory bodies.

Lucideon's ISO 17025 accredited laboratories, and expertise in chemical, physical, microstructural, microbiological and surface analysis, ensures your orthopaedic implants are ready for regulatory submission.

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Resources

  • White Paper

    Cleaning and Sterilization Validation of Reusable Medical Devices
    pdf (329 KB)

  • White Paper

    Regulatory Approval Testing of Hydroxyapatite - The Benefits of Using One Supplier
    pdf (365 KB)

  • White Paper

    Multi-Substituted Hydroxyapatites and the Role They Can Play in Advanced Bone Replacement Solutions
    pdf (848 KB)

  • White Paper

    Medical Devices - Cleanliness Validation
    pdf (793 KB)