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In Case You Missed It: Top 10 Gray Sheet Stories In April

A podcast interview and a feature story delving into the recent international ISO 13485 quality systems standard revision were the most popular items at TheGraySheet.com last month. Our continuing coverage of off-label communication questions in the courts and the laboratory-developed test debate attracted attention, along with a piece on biocompatibility testing tips from FDA officials. Also: popular Gray Sheet podcasts from April.

The recent international ISO 13485 quality systems standard continues to capture the interest of readers of The Gray Sheet. The two most-clicked online items in April highlighted the topic, including an exclusive podcast interview with quality and international regulation guru Kim Trautman, who recently left FDA, and a feature article.

A piece looking at the implications of the recently concluded Vascular Solutions Inc. off-label case was also popular, along...

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