Emergo Group is an ISO certified consulting firm

Surprisingly, many medical device consultants that offer quality management system consulting have not attained ISO certification themselves. Emergo Group is an ISO registered consulting firm that specializes in medical device quality assurance and regulatory affairs consulting. A copy of our ISO certificate is shown below.  ISO 9001 is focused on process improvement and customer satisfaction whereas ISO 13485 puts emphasis on meeting national regulations. Although we specialize in helping medical device companies implement ISO 13485, we do not sell or manufacture medical devices and this is why we maintain ISO 9001 certification instead. We’re focused on customer satisfaction!