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“Our products meet rigorous internal safety standards, international standards, as well [as] the standards of the FDA and other regulatory bodies,” the company said. Read More
The nerve stimulator places a small device equipped with electrode contacts and an embedded chip in the patient’s body through a needle that is paired with a wire receiver. Read More
The FDA uncovered serious complaint handling and CAPA deficiencies during an inspection of Alpha Source’s Milwaukee, Wisconsin facility from Jan. 17 to Feb. 2 and handed the firm an eight-item Form 483 at the close of the inspection. Read More
An FDA inspection of Southwest Technologies’ Kansas City, Missouri-based facility in February and March uncovered 13 observations, most relating to quality system failures and failure to track nonconforming products and submit Medical Device Reports. Read More
The final guidance omits language from a draft document that said the regulatory authority “does not dictate how a manufacturer should prove that their medical devices have met the essential principles.” Read More