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Simplifying Global Compliance
Recommended Products
GMP Inspection Preparation Checklist: A Tool for Internal Auditing
This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
Biological Risk Evaluation and Management for Medical Devices
Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
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Reva Medical’s Fantom Encore Receives CE Mark
The expanded approval covers the Fantom Encore in 3.0 and 3.5 mm diameters.
FDA Seeks Comments on Technical Standards for Electronic Submissions
The agency wants to hear from stakeholders about “the use of technical specifications guidances and the data standards they contain.”
Research and Development