Kathleen Johnson
Kathleen Johnson, President

About MDA Approvals

Medical Device Approvals, Inc. was established in 2002 and is a regulatory consulting firm providing service to both emerging and established firms commercializing medical devices. 

We provide companies with support in the following areas; FDA regulatory strategy and submissions, assistance with design control and risk management documentation, and Quality Systems development and implementation.

Additionally, MDAI can provide the following services:

Regulatory Assessments for Investors

Investor Presentations
FDA Liaison

FDA Liaison

U.S. Agent services for Foreign Establishments

We are a small firm of network consultants who will give your company the attention necessary to move your project forward in a timely and cost-efficient manner.

Our principal consultant, Kathleen Johnson, has over 25 years working as a Nurse/Perfusionist and 12+ years as a regulatory consultant. Click here to get Kathleen's CV.

To discuss how Medical Device Approvals can help you achieve your regulatory objectives, please contact us at kathleen@mdapprovals.com.