Clinical Evaluation Reports (CER) –

Written by: Daniel Miranda, Globiox Consultant Clinical evaluation is a critical, ongoing task that must be performed by medical device manufacturers who market products in the European Union and seek to obtain or maintain a CE mark. This task is completed via creation of a clinical evaluation report (CER). A CER must be created prior

Regulatory

Globiox’s team of consultants collectively, have experience in navigating regulatory pathways for a variety of life sciences products including drugs, medical devices, and combination products in both the United States and the European Union.  The regulatory landscape is constantly evolving, and Globiox prides itself on staying in tune with the latest developments.  Here is a

Quality Management Systems

Globiox’s team of experts can assist you in nearly every facet of the simplest paper based quality management system (QMS) to the most advanced enterprise quality management system (eQMS). Our clients include Fortune 500 companies and start-ups alike. We have expert staff to handle it all in a mutually agreeable scope. Gone is the time