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Regulatory Testing & Strategy

Need support getting dental devices through regulatory approval?  Our regulatory testing and strategy service provides support at every stage, from design to regulatory submission.  We will get your products approved quickly and efficiently so you get to market faster and gain the competitive edge.

Our experts will ensure your dental products are ready for regulatory submission.  We have experience of working with several regulatory authorities, including the 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
  • Establishing and validating cleaning processes
  • Characterize new materials for biocompatibility and benchmarking
  • Full mechanical testing including fatigue
  • Establishing substantial equivalence
  • Validating FEA models, by testing to failure or using our new 3D-strain service.

If you need to prepare for regulatory submission it helps to have the people in the know on your side.  We provide quality data and technical support with full documentation.  In the heavily scrutinized area of medical device regulations it is reassuring to have experts on your side, who have prior experience of developing and implementing testing packages.

We will build a partnership with you, offering expert support and technical help should any problems occur with your dental product.

We have ISO 17025 accredited laboratories, with expertise in chemical, physical, microstructural, microbiological and surface analysis techniques.

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Resources

  • White Paper

    Cleaning and Sterilization Validation of Reusable Medical Devices
    pdf (333 KB)

  • White Paper

    Medical Devices - Cleanliness Validation
    pdf (812 KB)