Medical Devices and Technology Regulatory

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.

Hogan Lovells has you covered. 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 your regulators and the changing regulatory landscape. This means we can help to expedite FDA approval and CE marking and design programs to successfully launch products around the world, while ensuring continuing compliance. We can also help develop reimbursement strategies to ensure your hard work leads to business success, and we can build the necessary infrastructure for a transaction or initial public offering, when the time comes.

Unlike our competitors, we have a dedicated team of over 30 medical device experts, many of whom have worked for regulatory agencies and in private industry, and have backgrounds in biostatistics, medicine, biomedical engineering, material science, pharmacy 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.