Today’s guest is Kristinn Gylfason, Compliance Officer at Sidekick Health and a lawyer who specializes in privacy.

Sidekick Health was founded by two doctors, who worked for years treating patients with lifestyle-related illnesses. They explored ways to prevent chronic illnesses, help patients manage them, and improve their quality of life. Sidekick Health combines strong clinical validation with gamification, behavioral economics, and artificial intelligence (AI) to deliver engaging and personalized patient experience.

Previously, Kristinn worked as a consultant focusing on General Data Protection Regulation (GDPR) before joining Sidekick Health in November 2019. Since then, he has focused on registering Sidekick Health as a manufacturer of medical devices. In doing so, Kristinn has gotten involved more with quality matters. 

Sidekick Health’s platform is rated in the top 0.1% in quality by ORCHA, which has more than 30,000 users and clinical validation and successful customer launches across multiple therapeutic areas – ranging from type 2 diabetes to ulcerative colitis.

Key Takeaways:

• How to enter new markets
• Why quality is important for Software as a Medical Device (SaMD) companies
• How to scale your business while keeping culture top of mind 

Show Notes: 

Kristinn Gylfason on LinkedIn

Sidekick Health

General Data Protection Regulation (GDPR)

FDA - SaMD 

FDA - Classify Your Medical Device

Pfizer

ORCHA

eHealth Award 2020

No Rules Rules

Application to be on the show: From Lab to Launch

Qualio

Music by keldez

Qualio website:
https://www.qualio.com/

Previous episodes:
https://www.qualio.com/from-lab-to-launch-podcast

Apply to be on the show:
https://forms.gle/uUH2YtCFxJHrVGeL8

Music by keldez