The Food and Drug Administration (FDA) approval process for products containing software used in hospitals, diagnostic labs and medical devices is challenging, complex and costly. Companies that build these innovative solutions, and their customers, cannot afford to be less than 100% certain about these systems. Code Refinery, a private, seed funded triangle-based business, gives companies focused on building medical device and clinical diagnostic solutions complete confidence in their product's software and peace of mind that it will meet the highest standards for FDA compliance. Code Refinery's software solutions save companies time and money in getting their products to the marketplace. Some local clients include Advanced Liquid Logic, Amphora Corporation, bioMérieux, LipoScience, Scynexis, Sicel Technologies, Tecan and TriPath Imaging (BD Diagnostics).
FastTrac to Success
Code Refinery has been a member of CED since 1998 and has participated in many workshops, programs and conferences. The company was one of the first participants of the FastTrac® class in 1998 when they were known as "The Technology Integration Group." In 2002, the company rebranded and became Code Refinery. During FastTrac®, they met their attorney Fred Hutchison, and long-time mentor and advisor Orlan Johnson. Samir Dandekar, partner and director of business development for Code Refinery, now co-instructs the life science section of the FastTrac® TechVentureTM program. Dandekar enjoys giving back to CED's network of entrepreneurs by mentoring emerging companies. He is able to provide hands-on industry expertise related to medical devices and diagnostics thanks to his experience building Code Refinery.
Entrepreneurial Insight
The ability to network and interact with the entrepreneurial community has aided in the growth of Code Refinery by enabling them to reach potential customers and partners. "The opportunity to expand your circle of influence and establish meaningful relationships is a must in today's business climate," explains Dandekar. Dandekar adds that a solid confidant during the good times and not so good times is necessary for any start-up. Code Refinery's participation with CED has provided them the opportunity to network, expand their circle and learn.
Learn more about Code Refinery at www.code-refinery.com.
To learn more about CED membership or the programs mentioned above, visit www.cednc.org.