Medical Devices & Products

If manufacturing and marketing vital medical devices weren’t already a challenging process, remaining compliant in a fast-paced and ever-changing regulatory environment grows more difficult every year. We offer comprehensive counseling and advocacy, beginning with FDA-focused product development to Medicare coverage, coding, and payment. Our deep experience, as well as our familiarity with critical regulatory agencies, allow us to help our clients navigate the multitude of concerns that arise when marketing FDA-regulated products, and, where necessary, before federal courts. We partner with medical device and products companies in the U.S. and abroad to bring new and innovative and products to market, allowing our clients to protect designs, drive business growth and enhance and execute successful business strategies. Our regulatory counsel team — which includes former assistant U.S. attorneys, federal agency counsel, and regulatory counsel for global pharmaceutical and medical device companies — manages interactions with key government agencies and helps identify new opportunities in a highly regulated marketplace.