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:
- Can be provided for investors wanting to know a regulatory pathway of a device under consideration for funding.
- MDAI can provide a regulatory assessment for a company or person with a new idea seeking funding and needing to know what would be required to get on the US market.
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.