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Publications

Product Development

The following article was recently published by the Regulatory Affairs Professional Society (RAPS):

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The Real Secret to New Product Development, Regulatory Affairs Professional  Society (RAPS) Newsletter, May 2001

Simulation Testing

The following publications provide information about simulation testing requirements:

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Meeting the New GMP Simulation Testing Requirements: A 10-Step Approach for Mechanical Testing MDDI Magazine, March 1998, pp. 93-102

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Design Control Guidance for Medical Device Manufactures, FDA Guidance Document, March 1997

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Company Information

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Engineer Foresees Biotechnology Takeover MDDI Magazine, March 1998, pg. 16

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Transcript of MassMEDIC Presentation, December 1997

 

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