Engineering and integrating power supplies into the medical equipment industry poses many unique challenges, due in no small part to the potentially life-saving nature of medical machinery, instrumentation and devices. At Astrodyne TDI, our engineers understand specific medical compliance standards required to placate those challenges.
Earning an ISO 13485 certification in the year 2012, one of the world's foremost certification bodies, we have been able to emphasize our ability to ensure reliable and safe medical power supplies to the market. An ISO 13485 certification is an internationally recognized standard designed to regulate companies that develop and manufacture medical device that meet a demanding set of quality and safety requirements. This standard requires an organization to demonstrate the ability to provide medical devices that consistently meet customer requirements and regulatory demands applicable to the medical market.
After completing a 12-month effort that affected all of Astrodyne TDI's design, manufacturing, and quality processes, achieving an ISO 13485 certification has allowed us to continue expanding into regions of innovations beyond the current industry. With this certification, our commitment to better providing medical OEMs with significant research and development, design, and manufacturing capabilities from our various statewide and global facilities, has thus far been a success. Additionally, these resources allow us to provide custom-configured medical products that meet engineers in other locations in North America, Europe, and Asia.
Furthering our certification succession is one more way Astrodyne TDI is demonstrating that our processes exceed the internationally recognized standards of quality, reliability and safety that our customers have come to expect from us.