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 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:

 

  1. Providing quality products with competitive pricing
  2. Maintaining partnership with suppliers that provide quality products
  3. Providing friendly work environment for our employees
  4. Committing to meet customer requirements and to achieve highest level of customer satisfaction
  5. Providing post-production programs to ensure EmCyte products are continually monitored for compliance and performance.
  6. Aiming to grow domestically and internationally

 

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), 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.

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, K024080, K183205 and now K191564.  We have over 20 years of medical device manufacturing experience and continue to develop products that are on the cutting edge of medical excellence.

 

We use state-of-the-art manufacturing equipment in a modernized facility with certified clean rooms to deliver products with the highest safety and quality standard.

 

Our assembly and packaging operations are efficient and reliable, providing us with the ability to develop a variety of custom projects for dedicated customers.

Give us a Call

239-481-7725

Send us a message

support@emcyte.com

Visit our location

Fort Myers, FL 33916