A customer sold ambulatory cardiac event recorders based on trans-telephonic data transfer across analog phone lines that were becoming obsolete in the market. The customer required a next generation device that patients could more easily have their data transferred for analysis.
Design Solutions was brought in to design and manage a next generation of event recorders based on a cell phone modem platform. We designed a single enclosure system to compete with similar but larger two box systems that were currently on the market from our client’s competitors. Within a time frame of 13 months, Design Solutions completed the design of the project, worked with the client’s regulatory group for the 510(k) submission and received the necessary agency approvals including safety (IEC 60601) and cell technology (PTCRB) certification to market and ship the device. To date the customer has shipped more than 25,000 of these devices.
Working With Us
We take pride in our range of services to our clients. Our ISO 13485 certified design process assures our customers that we can fulfill their needs at every level of the medical device design process.