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Medical Device Labeling Requirements | VISTAAR

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The Medical device industry is well regulated by the FDA in the US, and many regional bodies internationally, including the EU MDD (Medical Device Directive) and the ASEAN MDD. These agencies detail requirements for the life cycle of medical devices from design, trials, documentation, labeling, packaging, delivery, and adverse event reporting – all in the name of make the most of device safety and providing the utmost opportunity for positive patient outcomes. Read more at – PowerPoint PPT presentation

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Title: Medical Device Labeling Requirements | VISTAAR


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Medical Device Labeling Requirements
www.vistaar.ai
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  • Agenda
  • Medical Device Labeling Requirements
  • Summary of labeling requirements for some
    important Countries
  • UDI requirements / Recent labeling updates
  • Understanding the US FDA UDI and EU MDR
    Regulations
  • Get your free copy of Whitepaper


www.vistaar.ai
3
Medical Device Labeling Requirements
  • The Medical device industry is well regulated by
    the FDA in the US, and many regional bodies
    internationally, including the EU MDD (Medical
    Device Directive) and the ASEAN MDD. These
    agencies detail requirements for the life cycle
    of medical devices from design, trials,
    documentation, labeling, packaging, delivery, and
    adverse event reporting all in the name of make
    the most of device safety and providing the
    utmost opportunity for positive patient outcomes.
    Managing the life cycle poses many challenges,
    most notably the challenge of meeting diverse
    requirements set by regional and local markets,
    and the constantly evolving nature of these
    requirements.

www.vistaar.ai
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Medical Device Labeling Requirements
  • Medical device labeling is any information
    assists patients or their lay caregivers in
    understanding the device its operation, care,
    and maintenance the way it interacts with the
    body to accomplish its purpose its place and
    purpose in the patient care regimen and any
    safety or disposal issues.
  • Medical device labeling is essential to assure
    safe and effective use of many, but not all,
    devices. It informs patients or their lay
    caregivers about proper use, risks, and benefits
    of the device in a language they can understand.
    Adequate directions for operating the devices are
    needed to make devices safe and effective. For
    example, as more patients use complex medical
    devices at home, medical device patient labeling
    becomes necessary to better communicate to the
    layperson how to operate the device.

www.vistaar.ai
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Topics covered in this Whitepaper include 
  • Summary of labeling requirements for some
    important Countries
  • UDI requirements / Recent labeling updates
  • Understanding the US FDA UDI and EU MDR
    Regulations

www.vistaar.ai
6
DOWNLOAD Medical Device Labeling Requirements
www.vistaar.ai
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Thank You!
  • Visit us at www.vistaar.ai
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