Useful Industry Links

Novella Clinical Resourcing
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U.S. Food & Drug Administration (FDA) Medical Device Guidance Documents
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FDA Code of Federal Regulations (CFR)
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FDA Center for Devices and Radiological Health (CDRH)
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European Medicines Agency (EMA)
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Medicines and Healthcare Products Regulatory Agency (MHRA)
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International Organization for Standardization (ISO) Quality Management System Requirements
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AdvaMed
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Medical Device Daily
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Fierce Medical Devices
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Med Tech News

by AdvaMed SmartBrief

Techne to pay $104M for Bionostics

Techne has agreed to pay $104 million to acquire Bionostics, a maker of products to validate whether in vitro diagnostic tool -More-

CAPA Violations Still the Top Issue for FDA:
FDA inspectors view a firm's CAPA program as an indicator of how well or how poorly a firm has a handle on its overall operations.
Read more...

	Chinese medtech market poised for continued growth
	BMI Espicom predicts the medical device market in China will grow 20% through 2018, with diagnostic imaging tools projected t -More-

	Eucomed
	Eucomed represents the medical technology industry in Europe. -More-