Vivos Inc has dedicated several years to developing and strengthening our Quality Management System (QMS). This topic is low visibility but very
important behind the scenes.
Any future human therapies must be vital in this area, and we anticipate strict FDA audits on all aspects of the way we conduct our business.
Fred Swindler, our Manager of Quality and Regulatory Assurance, is leading this effort. Fred has more than thirty years of experience in this arena, working with
several other companies throughout his career.
Our technical and medical data collection for product implementation now has close to a hundred signed secure documents. Working with some of the best companies in
this country has aided us in revising and improving more than once. This 'QMS' library defines all aspects of our specifications based on many months of optimization regarding our particle and
polymer/hydrogel components. Some of this effort has resulted in crucial intellectual property, which we have protected with patents, but much remains proprietary.
We are entering the final phase of validating our essential procedures. This process includes production to specification, sterility, shelf-life, and pre-mixing of
our components. This data will be necessary to address critical sections of the subsequent IDE submittal.