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Our Services

We provide expertise in a wide array of musculoskeletal medical device types.

Our regulatory services include:

  • Preclinical Study Design

  • Preclinical Protocol Development

  • Study Data Analysis

  • 510(k)

  • Premarket Approval (PMA)

  • De Novo

  • Investigational Device Exemption (IDE)

  • Agency Interaction

  • FDA Strategy Assessment

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Contact us

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