Terumo Medical Corporation

950 Elkton Boulevard
Elkton, MD 21921
Telephone (410) 398-8500, Fax (410) 392-7218


CERTIFICATE OF COMPLIANCE


Date: 12/27/2017

Lot number:

Product code:

Product Description:

1. All Terumo products are manufactured in accordance with established product specifications and in accordance with the US Food, Drug, and Cosmetic Act, Chapter 21, Part 820, pertaining to: Quality System Regulations (Current Good Manufacturing Practices for Medical Devices) GMPs.

2. All incoming raw material meets specified requirements for material type, grade, and physical/chemical properties. Quality testing and review is performed on all raw materials in order to provide production areas with the caliber of materials necessary to manufacture finished product devices that meet specifications.

3. The visual and physical controls are checked in accordance with Terumo Specifications based on EN/ISO standards. Quality testing and document review is performed prior to release of finished devices to assure product performance to specifications.

         - visual inspection                       : conform

         - physical performance                : conform



                                                                                                            Angela Riley
                                                                                                            Quality Assurance Supervisor
                                                                                                            Terumo Medical Corporation