SMI Solutions

SMI-Solutions provides global medical device regulatory and quality consulting. We can help you access the fastest growing device markets worldwide. Our experience providing regulatory and quality consulting to both contract manufacturing and distribution global partners made the creation of SMI-Solutions an obvious expansion. Our staff brings over 25 years experience to your regulatory and quality needs. Lead by Tish Anger; her experience in product registration/clearance, Quality Management system compliance (including ISO13485, 21CRF801 and Ordinance 169), validation and verification activities, sterilization and clean room requirements, and strategic regulatory planning will help you get to where you need to be faster.

Company’s Keywords:

regulatory affairs, quality management systems, medical devices