Mission Statement

EmCyte Corporation is committed to the continual development and improvement of devices used for autologous regenerative biologics and to the promotion of autologous therapies used to enhance the quality of life.

Quality Policy

EmCyte Corporation is committed to meeting customer requirements and enhancing customer satisfaction through continual improvement of its products, services and the quality management system. The management team at EmCyte Corporation, and all its employees, are committed to the quality of our products and stated quality objectives. We maintain an Integrated Management System to meet the regulations requirements of the 21 CFR PART 820, (CMDR)-SOR/98-282, MDD 93/42/EEC, and the standards requirements of CAN/CSA-ISO 13485-03 (R2013), ISO 13485:2003, ISO 13485:2012 and ISO 9001:2008. We comply with all applicable regulatory requirements and continually improve the effectiveness of our Integrated Management System.

Quality Manufacturing

EmCyte Corporation is a medical manufacturing company. Our devices are cleared for marketing through both CDRH and CEBR divisions of the FDA, under 510(k) BK050055, K070666, and k024080.  We have over 17 years of medical device manufacturing experience and continue to develop products that are on the cutting edge of medical excellence.

EmCyte's clean rooms are ISO 7. We utilize state-of-the-art quality equipment and scientific injection molding principles as well as stringent quality inspection procedures to deliver products with the highest standard of safety and functionality.

Our assembly and packaging operations are efficient and reliable, providing us with the ability to develop a wide variety of custom projects to meet customer requirements.

Give us a Call

239-481-7725

Send us a Message

Support@emcyte.com

Visit our Location

4331 Veronica S. Shoemaker Blvd., Suite 4

Fort Myers, FL 33916