About SMEDIX

We help companies bridge the development gap, enabling our customers to effectively commercialize innovative IVD products in a regulated environment. We have the IVD experience and the insight to bring Medical Software Products to market that meet the safety, quality and usability attributes required in the healthcare industry. We can do it faster and at a lower cost given our global presence, Agile methodology, and fewer project personnel resulting in efficient project execution with high quality.

Our industry-experienced leadership and highly skilled global engineering team have broad capabilities to address the software needs of our customers. We handle the full software development lifecycle of clinical diagnostic and medical device products by providing services in software development, software verification & validation and regulatory compliance consulting. Additionally, we have teams who are subject matter experts specializing in areas such as instrumentation and control engineering, machine learning, bioinformatics, remote diagnostics, cloud/IoT applications, laboratory information interfaces, test automation, mobile applications, globalization and localization. Our primary mission is to help our customers succeed and to build long-term relationships.