Proven track record in writing medical device software (Application, Embedded, Mobile and cloud). Experienced staff with years of experience in developing IVD software in a FDA regulated environment. We are cross platform and develop in .Net, Java, HTML5, Android, iOS and other technologies to meet our clients’ needs. We work seamlessly and with your team in an Agile development environment to help you meet your project milestones.
Our experience and knowledge of Medical Software Development, Governing Processes and Guidelines enable us to customize Software V&V solutions that best meet your product and Regulatory submission needs.
Our experts will work closely with your teams to develop software risk documentation relative to the software safety classification (A, B or C) to ensure compliance with Risk Management Process per ISO 14971 and IEC 62304.
Our Software Solutions and Services are compliant with FDA, TUV, UL and other governing regulatory agencies. We work closely with your Regulatory and Quality functions to ensure that software Design Inputs and Outputs meet set Guidelines and Standards.
Test Automation can be very effective to help reduce overall cost and time for conducting software verification activities. SMEDIX can help you implement Software Test Automation solutions within your budget constraints and the product’s overall lifecycle.
In order to reach a global audience with your software and applications, our expert team can help you with the localization and globalization processes. With the most advanced technologies SMEDIX can get your product ready for an international market.