Simplifying Global Compliance
The QMN Weekly Bulletin
Medical Devices / Regulatory Affairs
FDA Considers Prequalifying Device Development Tools
Dec. 20, 2013
The FDA’s medical device center may prequalify scientifically validated tools to support the development and regulatory evaluation of new devices. The plan, laid out in a Nov. 17 draft guidance, could ease reviews and speed the device approval process.
International Medical Device Regulatory Monitor
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