Medical Device and Technology Regulatory

Bringing a medical device to market involves addressing a host of issues: regulatory approval, patents, financing, manufacturing, distribution, and more. 

After your product debuts, the challenges continue throughout its life cycle, from running compliance programs to responding to enforcement actions. And if you’re operating globally, the last thing you want to do is to oversee a patchwork of different firms in different locations.

That’s where Hogan Lovells comes in. We operate on a global scale, coordinating among lawyers in offices in all of the world’s major medical markets to sequence and streamline regulatory approvals. In the U.S., we’ve been helping companies get new products approved by the Food and Drug Administration (FDA) since the Medical Device Amendments of 1976 was signed into law. 

We understand how to do things in a better way to expedite the FDA approval process, streamline how much data is needed for approval to be granted, and design programs to successfully launch products and ensure continuing compliance. We can also help you develop reimbursement strategies and build the necessary infrastructure for a transaction or initial public offering. 

We are unique in achieving all this because of our interdisciplinary team. Many of our lawyers have worked for regulatory agencies and in private industry, and have backgrounds in biostatistics, medicine, biomedical engineering, material science, and genetics, among other disciplines. This means we understand the technology and can make better arguments on your behalf. From inception and approval to debut and product maturity, we provide guidance that takes into account the complex considerations where business and compliance meet.

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