When one of the world leaders in medical technology needed outside verification expertise for their next-generation pacing system, they turned to AVISTA. While the company had used independent contractors before, this effort required a large team to support complex firmware testing. Because of a demanding timeline for product development and certification, they needed a strategic outsourcing partner that could quickly ramp up a flexible team to deliver on time.
AVISTA has vast experience with software and firmware testing in the medical device technology field for FDA 510(k) certification, including certification of implantable devices. Our experts worked with the manufacturer’s in-house engineers to perform software and firmware verification for the implantable medical device. In addition, the AVISTA team tested the communications protocol used to program the pacing device in the doctor's office.
AVISTA’s considerable technical and program management expertise in life-critical projects brought the project in on time and on budget.
AVISTA provided seasoned verification experts to assist the client in successfully completing the project on a tight schedule.
It was through AVISTA’s expert program management and engineering staff, as well as the considerable experience with FDA 510(k) certification, that the client was able to successfully complete the project on time, being the first medical technology company to provide this next generation medical technology to the medical profession.
During the verification cycle, the number of software engineers ranged from one to over a dozen.