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Industry News |
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Industry News : Archives |
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Global Trends
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US FDA Issues Two
Draft Guidance Documents To Facilitate Medical Device Studies
In Humans |
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The US Food and Drug Administration (FDA) has issued a draft
guidance aimed at fostering early-stage development of medical
devices within the United States. Doing early-stage
development is important to help stimulate US-based innovation
and contribute to medical research. The guidance document
contains new approaches towards early feasibility studies,
which are conducted in a small number of patients early in
device development, while providing appropriate human subject
protections. Such studies are necessary to resolve final
design issues before the device is ready for a large clinical
trial that is typically required for product approval. The FDA
is seeking a small number of companies that could pilot the
new approaches in the guidance. The results of the pilot will
help to inform the final guidance... |
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Archive
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Did You Know?
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About Risk Management For Medical
Devices |
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ISO 14971 defines risk as the “combination of
the probability of occurrence of harm and the severity of that
harm. Risk management for medical devices is “the systematic
application of management policies, procedures and practices, to
the tasks of analyzing, evaluating, monitoring and controlling
risk... |
Market
Trends & Analysis
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Capitalising On
India’s Growth Potential : Medical Device Industry Will Not Be
Left Behind
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- The Indian economy is growing strongly, and will
continue to provide a conductive macro-environment for the
industry to grow in.
- The government is increasing spend on healthcare; and
the Indian population is spending an increased amount of
money on healthcare as a percentage of disposable income.
- The disease profile is changing with an increase in
acute diseases along side growth of chronics.
- Health insurance is growing...
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