Regulation of medical devices in the United States is an interesting but challenging field. Many industry members enter the regulatory space through alternate channels such as nursing, engineering, clinical research, or technical writing. Regardless of how one lands a position as a regulatory professional, the learning curve can be steep and daunting for novice regulatory associates despite industry exposure or academic involvement.
One thing our group felt could ease the pain of regulatory acclimation is a one-stop shop for all top-level medical device resources pertaining to U.S. regulations.
The purpose of this blog "Never Use Whiteout" is to provide a launching point from which someone can begin and enhance their regulatory endeavors. We aim to provide introductory materials to guide and focus the medical device 'regulatory newb' while steering the murky waters of an ever-changing regulatory climate.
And what's with the title "Never Use Whiteout"? Go ask your Quality department.
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