preloader

Search Here

NEXT-GENERATION PACING SYSTEM

Project Scope

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.

Solution

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.

Project Results

AVISTA’s considerable technical and program management expertise in life-critical projects brought the project in on time and on budget.

Creation of the test designs/test cases for portions of the physician’s clinical interface, the wireless communications protocol, and the programmer
Creation of tests for supporting multiple languages (a total of five) on the programmer, as well as the visual examination of the user interface
Verification testing of the functions involving the format of messages between the implantable device and the programmer or the home monitor
Verification testing of the error detection and reset features of the implantable device
Verification testing of the communication protocol of the wireless telemetry feature between the implantable device and the programmer or the home monitor
Experts in verification testing

AVISTA provided seasoned verification experts to assist the client in successfully completing the project on a tight schedule.

Experienced program managers and software engineers

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.

Flexible staffing

During the verification cycle, the number of software engineers ranged from one to over a dozen.