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Arnold & Porter is a 1000+ lawyer firm with renowned regulatory experience, sophisticated litigation and transactional capabilities. We have one of the world’s foremost life sciences practices which includes assisting clients with the legal challenges confronting the development, approval, manufacture, and marketing of medical device products including companion diagnostics, mobile health and emerging technologies regulated by the European health authorities, the US Food and Drug Administration, and other regulatory bodies. Our deep bench of multidisciplinary lawyers advise on clinical trial complexities, developing and implementing approval strategies, market access, advertising and promotion, vigilance, compliance programs, responding to inspections and enforcement, and managing crises such as major safety issues, recalls and product liability