Consulting Services for the Medical Device Industry

Bringing innovative medical devices to market since 1993.

Regulatory experts can be difficult to find, especially at reasonable rates. Cadence Regulatory offers strategic counsel as well as medical device market application and document review services to the medical device industry. Having written more than 25 FDA 510(k) applications, Cadence Regulatory president Robert Wolfarth uses over 30 years of industry experience with all risk classifications of medical devices—including at three start-ups—to help guide your company to a successful product launch.

Mission Statement

Cadence Regulatory, LLC helps designers of new medical devices who lack knowledge base in the US regulatory process to achieve their goals in bringing their novel products to market.