Medical Device Testing: 21 CFR PArt 11 Compliance

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  • Опубліковано 19 вер 2024
  • Reliable results, trusted compliance: 21 CFR Part 11's role in securing medical device quality testing.
    Quality testing of Medical Devices ranges from syringe actuation (break loose and glide), needle sharpness and adhesion strength to Child Resistant Closure (CRC) torque. Even though there are different approaches to these test applications, one thing remains true - the need for compliance to 21 CFR Part 11.
    21 CFR Part 11 governs the access to, creation, modification and deletion of data to ensure data integrity.
    This webinar with will focus on the importance of Medical Device testing - methods and applications, while showing you how to achieve compliance to 21 CFR Part 11.
    What You’ll Learn:
    The importance of Medical Device testing
    Syringe actuation testing (break loose and glide force)
    Needle sharpness testing
    CRC (Child Resistant Closure) testing
    Factors that affect consistent and repeatable testing
    Achieving 21 CFR Part 11 compliance
    A leading designer and manufacturer of force and torque test equipment since 1977, Mecmesin offers precision test instruments and systems that are accurate, reliable and excellent value for money. We provide a tailor-made service creating the ideal testing platform, which is robust, easy to operate and gives top-level performance time after time!
    Mecmesin is a part of the Physical Properties Testers (PPT) Group, a multi-national holding company.
    Operating under ISO 9001 quality standards, Mecmesin test products are used to guarantee the quality of components, materials and finished products, from factory floor through to the R&D laboratory, in multiple industries.

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