At Nelson Hardiman, we understand that FDA regulatory compliance is the key to success for medical device companies. Our strong healthcare regulatory experience helps our clients navigate the competitive and evolving industry. From our catbird’s seat we keep an eye on the future for medical device technology and innovation, prepared to problem-solve the next legal challenge.

From 3D bioprinting of human tissue and smart probes/smart scalpels to electromagnetic acoustic imaging, wideband medical radar, and nanbots, we keep our finger on the pulse of emerging medical device technologies and industry developments. We are constantly creating, innovating, and enhancing business, litigation, and regulatory strategies to keep our clients at the forefront of change. We apply our industry-leading experience to help medical device companies resolve legal challenges as they explore and conquer new frontiers in medical device advancement.

Our Work Includes:

  • HIPAA and Data Privacy/Security Laws Advised medical device companies on HIPAA and other health data security and privacy matters and development of privacy compliance programs.
  • Licensing and Product Agreements Documented significant domestic and international IP licensing, manufacturing, marketing, and distribution agreements for medical devices, and related products.
  • Life Sciences Our life sciences experience includes work for medical device companies.
  • Marketing Campaign Compliance Evaluated medical device company marketing campaigns for compliance with the federal Anti-Kickback statute and other fraud and abuse laws.
  • Strategic Consulting Our work encompasses strategic consulting for medical device manufacturers, including significant lobbying and governmental representation experience.