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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International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
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Medicines and Healthcare Products Regulatory Agency (MHRA)
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ICH Good Clinical Practices
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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

Device tax could add $175M to Medtronic's annual costs, exec says

The proposed 2.3% medical device excise tax set to begin next year will cost Medtronic $125 million to $175 million a year, s -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...

	SafeStitch Medical lands $8.3 million from stock placement
	Miami-based SafeStitch Medical, a maker of devices for endoscopic and minimally invasive procedures, has raised $8.3 million -More-

	Global demand for pacemakers fuels profit growth for Medtronic
	Medtronic posted a 1.2% growth in profits during the company's fiscal third quarter that ended Jan. 27. -More-