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Technical Considerations for NonClinical …

    https://www.fda.gov/media/123272/download
    Given the complex properties of nitinol, characterizing the thermomechanical behavior of nitinol devices presents unique considerations when assessing safety and effectiveness. Previous...

Non-Clinical Assessment of Medical Devices Containing …

    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/technical-considerations-non-clinical-assessment-medical-devices-containing-nitinol
    Device manufacturers have used nitinol’s unique properties (i.e., pseudoelasticity and shape memory behavior) to design innovative medical devices that would not be …

An Overview of Nitinol: Superelastic and Shape Memory

    https://www.medicaldesignbriefs.com/component/content/article/mdb/pub/features/articles/23077

    Nitinol medical device design considerations

      https://www.researchgate.net/publication/228831776_Nitinol_medical_device_design_considerations
      Nitinol is quite an expensive material [241] owing to extensive processing costs and a very limited number of suppliers. ... ... However, nitinol has some limitations …

    Nitinol University - Confluent Medical

      https://confluentmedical.com/tech-center/nitinol-university/
      Nitinol University (NU) is a one-day training course hosted by Confluent Medical Technologies designed to provide the medical device industry with a fundamental …

    NITINOL MEDICAL DEVICE DESIGN …

      https://uploads-ssl.webflow.com/59fcbaf103e295000131288b/5a3192700672a700015ad6dd_Nitinol_Medical_Device_Considerations_SMST00.pdf
      the key characteristics that the nitinol component needs to fulfill. In all cases, and not only from a regulatory perspective, one shall demonstrate the safety and efficacy of the …

    Understanding nitinol implant design and …

      https://www.medicaldesignandoutsourcing.com/understanding-nitinol-implant-design-manufacturing/
      Its properties, combined with high fatigue resistance and an ability to provide constant force over a wide range of displacements, makes it ideal for use in …

    Manufacturing Nitinol Medical Devices

      https://npxmed.com/nitinol-medical-devices/
      Manufacturing Nitinol Medical Devices. Nitinol is an alloy that is made up of mostly Nickel and Titanium. We take advantage of two primary unique properties with Nitinol, …

    Nitinol Devices & Components - Confluent …

      https://confluentmedical.com/nitinol-devices-components/
      NDC® Nitinol Materials, Manufacturing, and Technical Services by Confluent Medical Technologies. Since 1991 the NDC brand has been trusted for delivering the highest …

    Nitinol Medical Device Considerations SMST00 PDF

      https://www.scribd.com/document/244031796/Nitinol-Medical-Device-Considerations-SMST00-pdf
      Nitinol_Medical_Device_Considerations_SMST00.pdf - Free download as PDF File (.pdf), Text File (.txt) or read online for free. Scribd is the world's largest social reading …



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