Medical device development : regulation and law /
- Medical device development : regulation and law /
- Kahan, Jonathan S., author.
- MCPHS Boston
- The framework for regulation of medical devices -- The 510(k) premarket notification process -- Device modifications requiring a 510(k) notice -- FDA regulation of medical device software -- The investigational device exemption application : overview of the IDE process and humanitarian devices -- Medical device clinical studies -- The premarket approval application -- Review of a premarket approval application -- PMA supplements -- Medical device reclassification -- The regulation of in vitro diagnostics -- The quality system regulation -- Compliance -- Medical device exports and imports -- Product jurisdiction and the regulation of combination products -- Working well with FDA.
- Online access:
- No online access
- Library holdings:
MCPHS Circulation - Boston Campus
KF3827.M4 K34 2014