Qualitest Group Delivers Turnkey Healthcare Remediation Project Following an FDA Warning

Client Overview

A respected global healthcare corporation received an FDA warning for a sophisticated medical device. The company had failed to meet the required quality level in their testing requirements, documentation and maintenance procedures.

After further investigation, the healthcare corporation understood that there is a significant gap between their current status and the desired quality and testing level. To resolve the issue and remove the FDA warning, a remedial project was required.

Business Needs and Objectives

Due to the severity of the FDA warning, the healthcare corporation needed a fast resolution. However, all their resources were engaged in developing the next product releases. The healthcare corporation needed to find a solution that would deliver a remedial project quickly and effectively without compromising the company’s development roadmap. The healthcare corporation decided to seek qualified vendors, with the required healthcare software testing expertise, that could deliver a turnkey in the required time frame.

The Qualitest Solution

Following a short and intensive bid process, Qualitest Group was selected to provide a managed testing services solution delivered in a turnkey model across two continents. The solution’s scope includes a complete healthcare system process design, medical system performance testing, verification and validation.

Within 3 weeks of launch, Qualitest Group assembled a number of dedicated teams in multiple locations including Ohio and Haifa Israel. The team included a total of about 30 system engineers, testing and quality assurance experts. The group was able to start working quickly, operating through a Qualitest Test Center of Excellence, located in close vicinity to the customer’s premises as well as at the customer premises based on the customers’ need.

With the fast pace of technology, more and more companies are finding it tough to maintain the required quality standards while moving forward towards their development goals. Whether a company requires ongoing software testing services, or a specific high-intensity testing project – there is a growing trend of turning to managed testing services.

Testimonial

At Qualitest Group, we are keenly aware of the rigorous requirements imposed by the FDA on healthcare companies,” said Aviram Shotten, Business Manager & Sr. Test Specialist at Qualitest Group. “Our Healthcare testing, verification and validation services are specifically designed to help meet and maintain the necessary high quality standards for healthcare Systems. This selection by a leading healthcare corporation is a further testament to the high level of our medical testing services and our proven ability to lead and successfully deliver time-critical projects.