Eagle Creek Consultants, Inc.

Indianapolis, IN

Eagle Creek Consultants, Inc. is a consulting firm focused on supporting organizations who design and/or manufacture medical devices who will comply with US and European (EU) regulations. Consultants can aid organizations with the development of regulatory strategies, including discussions with regulatory agencies regarding their classification or submission strategies. Eagle Creek Consultants can also prepare or revise US and EU regulatory submissions, include review of submission content for suitability and completeness and responding to regulatory agency questions on submission content. On the quality management system side, Eagle Creek Consultants can aid in preparation and implementation of quality system procedures and processes or can aid in modifications to existing quality systems to address new regulatory needs or new product requirements. On the post-market side, Eagle Creek Consultants will aid customers in evaluation of post-market design changes for regulatory reporting needs and modifications to existing procedures. Our consultants can also aid in responding to regulatory notices, such as US FDA 483 observations or warning letters. Eagle Creek Consultants also performs audit activities to assess the readiness of your quality system for regulatory inspection.

Member Number: 227, Basic

Member Since: 2024