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 with our latest tips and trends on quality and inspection...