The patient. First concern for Cousin Biotech.
The quality policy implemented by the company is focused on the idea to design and manufacture products that meet the regulatory standards and having for the patient a favorable risk / benefit ratio.
The compliance with regulations is an integral part of the specifications of the company. The quality management system of Cousin Biotech is certified ISO 13485 et MDSAP , its products with CE label meet the requirements of the European directive 93/42/CE. Cousin Biotech incorporates also the requirements from 21CFR part 820 and distinguishes itself by its performance in terms of export regulations, whether to the United-States, Brazil, Taiwan, Australia or Japan.
From the idea to the end of the life of the device, everything is thought and included in the control method and quality management. A dedicated team, composed of technical expoerts and specialists in regulation matters ensures the technical CE files are updated, deals with risk management, registers medical devices outside of Europe and also launch and monitor clinical researches.
Post market clinical studies are conducted to reinforce and confirm the clinical evidence of our products.
For innovative products, prior clinical studies are carried out to prove that the product will resolve an unresolved problem. These studies last for at least 3 years.