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How to Maintain a Quality Culture during Explosive Growth with Kristinn Gylfason at Sidekick Health

How to Maintain a Quality Culture during Explosive Growth with Kristinn Gylfason at Sidekick Health

FromFrom Lab to Launch by Qualio


How to Maintain a Quality Culture during Explosive Growth with Kristinn Gylfason at Sidekick Health

FromFrom Lab to Launch by Qualio

ratings:
Length:
22 minutes
Released:
May 27, 2021
Format:
Podcast episode

Description

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 marketsWhy quality is important for Software as a Medical Device (SaMD) companiesHow to scale your business while keeping culture top of mind Show Notes: Kristinn Gylfason on LinkedInSidekick HealthGeneral Data Protection Regulation (GDPR)FDA - SaMD FDA - Classify Your Medical DevicePfizerORCHAeHealth Award 2020No Rules RulesApplication to be on the show: From Lab to LaunchQualioMusic by keldezQualio 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
Released:
May 27, 2021
Format:
Podcast episode

Titles in the series (97)

Stories from the front lines of life sciences. Hear how founders, investors, engineers, scientists, and quality experts are innovating to save lives. You’ll hear founders share their insights from launching and scaling their business, investors giving their outlook on funding, industry experts unfolding their latest insights and research, and quality professionals offering advice to navigate the regulatory maze and avoid audit pitfalls. We interview the brightest people in the life sciences industry specifically biotechnology, medical devices, healthcare, pharmaceuticals, software as a medical device (SaMD), contract service providers, and therapeutics. Episodes are about 20-30 minutes. Tune in and leave inspired to bring your life saving products to the world. Passionate about life sciences and want to be on the show? We’d love to chat. Please fill out this short application: https://forms.gle/Yp7uKnSXTCPtTdRcA