iso 13485 certification body in UK (1)

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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.

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• 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

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