Gregory Adam Kass

With a deep familiarity of ISO 13485 and FDA's Quality System Regulation, Greg frequently works with firms to address regulatory violations such as FDA Warning Letters; It Has Come To Our Attention Letters; product recalls, corrections, and removals; and quality system deficiencies.  This includes drafting regulatory communications, interfacing with FDA, and leveraging prior experience to achieve desired results. 

Medical device firms rely on Greg's high-quality regulatory advice when buying, selling, investing in, or restructuring medical device firms or assets.  His collaborative approach, thoughtfulness, and working knowledge of FDA medical device regulation and enforcement trends preserves value, significantly minimizes the probability of post-close surprises, and reduces overall risk.   

Greg leverages over a decade of clinical healthcare experience to ensure that when presented with fast-paced and high-stakes regulatory challenges, good judgment and sound advice prevail.