Rebecca Andersen Email and Phone Number

Cosulting in the Medical Device Industry

Pre and post market Regulatory Affairs including Risk Management.

Global submissions, licenses, and registrations. Technical Files, Dossiers, Declarations of Conformity. etc. Specializing in domestic and international compliance.

Corporate Regulatory Affairs is responsible for Global Device Registration, listing, approval and control. Responsibilities include 510(k)’s, CE Marking, Technical Files, and specialty submissions. The Hospira device product line includes drug device combination devices such as pre-filled syringes and the i-Secure device, while our device lines include various types of infusion pumps, with a full line of supporting administration sets. Other products include various monitors, Medical Calculators, and Medication Management Safety Suites. Regulatory works closely with design teams to ensure that products and documentation adhere to regulatory plans, thereby allowing submissions to be developed and processed in a timely manner. Regulatory Affairs also meets as needed with FDA and other agencies to discuss strategic positioning, applicability of standards and appropriate regulatory pathways.