iso 13485 certification body in UK - PowerPoint PPT Presentation

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iso 13485 certification body in UK

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ISO 13485 is a quality management system standard for medical devices & equipment. – PowerPoint PPT presentation

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Title: iso 13485 certification body in UK


1
ISO 13485 CERTIFICATION
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The uses of ISO 13485 Certification for medical
devices?
  • As a medical device manufacturer, even if you not
    have the ISO 13485 certification, you have to
    comply with the applicable regulatory
    requirements to market your products.
  • Compliance with regulatory Classes requirements
    is given equal importance in ISO 13485, with the
    latest version putting additional emphasis on
    this factor. The Food and Drug Administration
    (FDA) is a federal agency of the United States of
    America responsible for safeguarding and
    maintaining public health through the regulation
    and supervision of medical devices and other
    products.
  • The Center for Devices and Radiological Health
    (CDRH) is the authority for regulating and
    approving medical devices under the domain of the
    FDA

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  • The classification procedure and market approval
    processes are fully explained in the 21 CFR Part
    860 (Code of Federal Regulations for Medical
    Device Classification Procedures). The FDA, in
    the United States, permits devices to access the
    market through two regulated paths. The easiest
    and most widely used is the 510(k) process (which
    is titled after the CFR section).
  • When a supplier can prove that its newly
    Introduced device is Similar to a former
    officially supplied
  • Devices placed into Class I offer the least
    potential for harm to the user and/or the
    patient. These devices commonly have a simpler
    design than those devices that fall into the
    other two classesmedical device, it can access
    the market with the permission of the FDA as the
    defined controls required in this process are
    met.

4
  • Class II Class II devices are more sensitive in
    terms of life support than those in Class I.
    Devices in Class II are controlled with a higher
    level of assurance than Class I devices, and are
    regulated by the FDA to ensure that they perform
    their intended functions well without resulting
    in any injury or damage to the patient or user.
  • Such eg, of Class II devices are infusion pumps,
    acupuncture needles, air purifiers, powered
    wheelchairs, pregnancy test kits, and surgical
    drapes.
  • The Food, Drug and Cosmetic Act under Section
    510(k) mandates that medical device suppliers who
    want to sell their devices in the Class II
    category must submit registration showing their
    intent to market a device.
  • ISO 13485 Certification in Quality Management
    System is the process of application submission
    known as the Premarket Notification (PMN), and is
    also referred to as 510(k).
  •  iso 13485 certification body in UK

5
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