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The platform is already compliant with EU MDR Class 1, ISO 13485, ISO 27001, ISO 27701, IEC 62304, and GDPR.
July 17, 2023
By: Michael Barbella
Managing Editor
Wellthy Therapeutics has completed its U.S. Food and Drug Administration (FDA) 21 CFR Part 820, FDA 21 CFR Part 11, and HIPAA certification for its disease-agnostic, modular, software-as-a-medical-device (SaMD) platform. The Wellthy Therapeutics platform is already compliant with EU MDR Class 1, ISO 13485, ISO 27001, ISO 27701, IEC 62304, and GDPR (General Data Protection Regulation), demonstrating its dedication to delivering digital health solutions that consistently meet global regulatory requirements. The platform simplifies the ability for pharma, HUBs, providers, and health plans to launch and scale globally compliant digital health and SaMD solutions. Clients leverage the platform to configure and commercialize their own customized digital health and SaMD solutions that are deployable in a matter of weeks and at a fraction of traditional costs, while addressing their specific business goals and complex patient needs. More than 150,000 patients have benefitted from Wellthy Therapeutics’ platform so far, highlighting the value that the company’s platform brings, and its continued leadership in the clinical outcomes and patient engagement space. “Our recent US certifications, along with our existing compliance with other international standards, reinforce our mission to revolutionize digital health worldwide,” Wellthy Therapeutics CEO Abhishek Shah stated. “Our modular SaMD platform has enabled medication and health brands to improve patient identification and onboarding, substantially differentiate products, increase adherence, reduce overall cost of care and medical claims; all while improving patient quality of life and solving for unmet patient needs. In doing so, we are pushing the boundaries of medicine and creating a brighter future for patients around the world.” Wellthy Therapeutics is a global developer of digital therapeutics. It builds and launches customized digital health solutions, powered by its disease-agnostic, modular, software-as-a-medical-device (SaMD) platform.
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