Tandem Health × Scarlet
EU MDR certification for an LLM-based medical device
“We’ve been amazed by Scarlet, particularly their AI expertise.”
Yan Peng Zhao
Head of Medical Compliance, Tandem Health
The challenge
Tandem Health wanted to certify their AI scribe and clinical coding assistant with a Notified Body that understands generative AI
Customer snapshot
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Sweden-based GenAI start-up, with a device being used by 200,000 NHS professionals
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Developed an AI scribe and clinical assistant tool, ensuring patients are put on consistent and appropriate clinical pathways, meaning they don’t miss out on crucial treatment and follow-up
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Looking for a Notified Body with deep knowledge of cutting-edge AI to certify an LLM-based device
The outcome
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CE marking for their AI scribe and clinical assistant tool
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An EU MDR certification in just 2 months
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Product in use in over 5,000 healthcare organisations
“We simply couldn't have found a better Notified Body than Scarlet to achieve this huge milestone. Their support throughout the entire process was incredible.”
Yan Peng Zhao
Head of Medical Compliance, Tandem Health
