DeepHealth × Scarlet
Supporting rapid consolidation of a global SaMD-manufacturer portfolio
“With Scarlet there’s been a real sense of: ‘Listen, we want to see you be successful as well, so how do we make that happen?’”
Nathan Hunt
Head of Quality Assurance, Regulatory Affairs, & Compliance, DeepHealth
The challenge
DeepHealth wanted to achieve several ambitious regulatory objectives and needed a responsive, innovative, high-touch Notified Body with SaMD expertise
Customer snapshot
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A global leader in AI-powered health informatics solutions with more than 2,800 customer contracts worldwide, and navigating more than 10 million patients monthly
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Engaged in acquisition and integration of multiple AI/ML SaMD manufacturers to complement comprehensive suite of ground-breaking devices
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Looking for a partner Notified Body capable of handling complicated regulatory needs to bring cutting-edge products to market
The outcome
In under 6 months of collaboration, Scarlet enabled DeepHealth to:
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Bring 8 CE-marked products to market
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Achieve multiple certificate transfers
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Process 3 significant changes
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Complete an EU MDR transfer, significant change, and re-certification all in only 5 weeks
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Obtain a multi-site ISO 13485 certification
“Scarlet's ability to innovate and adapt allowed DeepHealth to maintain regulatory compliance across a number of complex integration and expansion projects.”
Nathan Hunt
Head of Quality Assurance, Regulatory Affairs, & Compliance, DeepHealth
