Meet Qualio Plus: Sidekick Health Chooses Qualio for Audit-Readiness
Sidekick Health is a software company founded by medical doctors and specialists that operates a gamified digital care platform designed to help people manage chronic conditions, overcome illnesses, and make lifestyle-related changes to enjoy happier and healthier lives. Due to the nature of its work, some of the content the company makes is considered software as a medical device. Sidekick Health — which was founded in 2014, has 60 employees, and is headquartered in Iceland — closed a $20 million Series A round in October 2020.
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
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.