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.
EmCyte Corporation mission is to commit 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. EmCyte missions can be fulfilled by the following key objectives:
EmCyte maintain an Integrated Quality Management System (IQMS) to meet the medical device regulations requirements of the FDA Quality System Regulations (21 CFR Part 820), Canada Medical Device Regulations (CMDR SOR/98-282), EU Medical Device Directive (MDD 93/42/EEC) and the medical device quality standard requirements of EN ISO 13485:2016. We will comply with all applicable regulatory requirements and continually improve the effectiveness of our IQMS. The management team will periodically review the performance of the IQMS and our quality objectives. This quality policy is regularly communicated to our employees and reviewed by the Management Team for its continuing suitability. Our employees will recognize EmCyte Corporation as the best organization to work for. We will maintain a profitable operation to establish our competitive position in the market.
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.
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