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Sidekick Health chooses Qualio for audit-readiness
Technology Category
- Functional Applications - Enterprise Resource Planning Systems (ERP)
Applicable Industries
- Healthcare & Hospitals
- Software
Applicable Functions
- Business Operation
- Quality Assurance
Use Cases
- Regulatory Compliance Monitoring
- Remote Collaboration
Services
- System Integration
- Training
The Challenge
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. 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.
About The Customer
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.
The Solution
Sidekick needed a new solution for quality management. Since they were particularly interested in automating the process as much as they could, the company knew it needed an eQMS. After looking at quite a few eQMS vendors, the Sidekick team ultimately selected Qualio as their final choice. Also of note is the fact that a potential investor recommended Qualio to the company’s COO and CEO, while Sidekick was in the process of raising its Series A. “That confirmed our belief in Qualio,” Gylfason explains.
Operational Impact
Quantitative Benefit
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