Sterling Medical Devices participated in the development of a catheter system. The client purchased a number of catheter products from another company. The new products needed the Design History File (DHF) documents reviewed and updated to meet the acquiring company’s quality system, as well as standards that were released after the products were developed.
The catheter products included adult and neonate catheters used by trained personnel in a hospital setting. Additionally, the products included kits of supporting items such as drapes, scissors, medication, and other supporting products.
The existing DHF was reviewed and updated as needed for each product including support applications. The updates included enhancing the requirements, implementation, and validation documentation to meet the client’s Quality System requirements.