STI has previous experience in developing a medical device under compliance with FDA Quality System Regulations (21 CFR Part 820).
STI maintains policies and procedures for all controls mandated by these regulations. These controls include but are not limited to: management controls, design controls, purchasing controls, document controls, acceptance activities, and corrective and preventative action.
In addition, STI’s clinical trial management adheres to Good Clinical Practices in both domestic and international locations.
STI seeks regulatory expertise from their Regulatory Affairs Specialist as well as outside consultants. STI also has an experienced clinical affairs expert on staff. The company is well poised to design and manage all clinical studies on its own.
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