Committed to Quality and Patient Safety

Capsule is committed to the highest level of quality management and design controls to ensure delivery of the safest and most effective products possible.  We have always known that it was important to have the right risk management processes in place, especially since our solution is deployed in the healthcare environment.  This is why we chose to receive FDA 510(k) clearance on our medical device data system (MDDS) solution, even though it is not currently a requirement in the industry. We even chose to go through the more rigorous requirements of a Class II medical device such as a cardiac monitor.  Why?  Because we feel that transmission of patient data is too important to safe and effective care delivery to not meet this level of classification. 

To date, Capsule is still one of the only providers of a medical grade, medical device data system (MDDS)solution that is FDA 510(k) cleared as a class II medical device. And Capsule continues to pursue certifications that prove our commitment to quality. We recently received ISO-13485 certification demonstrating that we successfully implemented a QMS that conforms with the worldwide quality management system standard for medical devices.  This certification focuses on the unique and rigorous requirements for companies involved in the development of medical devices and further proves our commitment to quality and risk management.

Our FDA clearance and ISO certification simply provide further proof that Capsule's medical device data system (MDDS) solution is the most established one available and therefore is the safest for hospitals to implement. Why? Because Capsule knows what it takes to connect.

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