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Live Webinar ISO 10993 - Valutazione Sicurezza Biologica [ITA] - On Demand

185.00€
Disponibilità: ALTA
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Biological Safety Evaluation ISO 10993 - Risk Approach - In Vivo - In Vitro Test - Technical File - On Demand Live Webinar - [ITALIANO]

This live webinar course will provides guidance on biological safety evaluation and ISO 10993:2009. In Particular will discuss the following points:



  • ISO 10993:2009 Biological Safety Evaluation
  • Risk Approach
  • In Vitro Test
  • In Vivo Test
  • Biological Safety Evaluation and Technical File
    • Why Should You Attend:

    A medical device or material that comes in contact with the patient's body is expected to perform its intended function without resulting in any adverse effect to a patient. Potential adverse effects can range from short-term (acute) to long-term (chronic) adverse effects to the body such as mutagenic effects. For this reason, medical devices are typically subject to biological evaluation and biocompatibility testing to assess the interaction between a device and tissue, cells or body fluids of the patient.



    Biocompatibility testing answers two fundamental questions:



    • Is the material safe?
    • Does it have the necessary physical and mechanical properties for its proposed function?



    Who Will Benefit:
    • Manufacturing
    • Quality Control
    • Quality Manager
    • Quality Engineer
    • Regulatory Affairs specialist
    • R&D Engineer
    • Pharmaceutical Engineer
    • Validation Engineer
    • Process Engineer