CircuLite(R) Receives ISO 13485 Certificate Of Registration For The Synergy™ Pocket Micro-Pump
CircuLite, Inc. has announced that it has received ISO 13485 certificate of registration from BSI Group for the Company’s Quality Management System in Saddle Brook and Aachen for the design, manufacture and distribution of the Synergy™ Pocket Micro-pump for the treatment of chronic heart failure. ISO 13485 is a regulatory certification for the international medical industry, created by the International Organization for Standardization (ISO), which defines standards for the design, development, production and distribution of medical devices, and also ensures conformity with certain quality controls in the development of safe and effective devices.
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