Meet Qualio Plus: Sidekick Health Chooses Qualio for Audit-Readiness

At a very high level, Sidekick has two different kinds of products: those that are regulated and those that are not. For example, a program designed to help patients manage diabetes effectively by telling them to go for a walk and eat healthier isn’t considered a medical device. On the other hand, apps designed to treat patients with chronic heart failure and peripheral artery disease are classified as medical devices.

Recently, Sidekick decided to increase the number of products in their portfolio that required a CE mark. Lacking a purpose-built electronic quality management system (eQMS), the Sidekick team saw that they would need to fill out a ton of paperwork and create a lot of documentation over and over again with each new product.

“We quickly realized that we were going to drown in paperwork,” explains Kristinn Gylfason, Sidekick’s Compliance Officer. “We saw in the near future that we would have to write all of these policies, procedures, and SOPs again and again and again.”

Sidekick had been using another software to maintain and manage all documentation. While the platform might have done the job well enough at a smaller scale, the company was looking for a long-term solution that could keep pace with their growth.

“What I was mostly afraid of was the ever-changing nature of the software,” Gylfason continues. “It could change two or three times a week — or twice a day even.”

Enable Audit-Preparedness With Qualio

Read the full case study here.

To learn more about how your software as a medical device company can use Qualio to achieve audit-readiness and make the process of securing regulatory approval that much easier, request a demo of Qualio today.