Medtech is transforming the world at a rapid pace. Medical device companies must constantly evaluate whether and to what extent their pioneering technologies are regulated, secure necessary approvals around the world to bring their products to market, and ensure reimbursement where appropriate. At the same time, they must take steps to protect and defend their products from a host of competitors and from product liability lawsuits that threaten innovation. Established and emerging medical device companies seek the advice of our lawyers in navigating the ever-evolving challenges and opportunities inherent in this industry. Our FDA regulatory, healthcare, patent litigation, and product liability lawyers have a nuanced understanding of the multifaceted issues confronting medical device companies in their day-to-day operations. Members of our team have deep knowledge of regulatory pathways, and have counseled many clients on matters raising a variety of medical device regulatory issues. Sidley’s global platform and multidisciplinary practice offerings allow us to seamlessly counsel multinational medical device companies as they navigate the varying regulatory regimes across the U.S., Europe, and Asia.
We harness our lawyers’ breadth of knowledge to assist clients in high-profile matters involving a range of premarket approval and 510(k) cleared medical devices, including:
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