Case Studies Sidekick Health chooses Qualio for audit-readiness

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	Sidekick Health chooses Qualio for audit-readiness

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
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. Read More
About 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. Read More
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. Read More Log in to view content
Contents

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

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 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.

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.

Impact #1	Ready to Scale: Currently, Sidekick is growing rapidly; the company has grown from 20 to 60 people recently, and plans to continue to scale in 2021. Suffice it to say that this explosive growth has kept the team busy.
Impact #2	Well-Positioned to Enter the U.S. Market: Looking ahead, Sidekick has its sights set on tapping into the U.S. market. To do that, they will need to secure FDA approval on some products as a software as a medical device organization.
Impact #3	High-Touch Onboarding: Shortly after Gylfason was onboarded by the Qualio staff, the Sidekick team hired a key position on the Quality team, and the company decided to hand over Qualio ownership to that individual.

Impact #1

Ready to Scale: Currently, Sidekick is growing rapidly; the company has grown from 20 to 60 people recently, and plans to continue to scale in 2021. Suffice it to say that this explosive growth has kept the team busy.

Impact #2

Well-Positioned to Enter the U.S. Market: Looking ahead, Sidekick has its sights set on tapping into the U.S. market. To do that, they will need to secure FDA approval on some products as a software as a medical device organization.

Impact #3

High-Touch Onboarding: Shortly after Gylfason was onboarded by the Qualio staff, the Sidekick team hired a key position on the Quality team, and the company decided to hand over Qualio ownership to that individual.

Benefit #1	Sidekick Health closed a $20 million Series A round in October 2020.
Benefit #2	The company has grown from 20 to 60 people recently.

Benefit #1

Sidekick Health closed a $20 million Series A round in October 2020.

Benefit #2

The company has grown from 20 to 60 people recently.

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Overview

Sidekick Health chooses Qualio for audit-readiness

Operational Impact

Quantitative Benefit