Completes FDA CFR Part 11, FDA CFR Part 820, and HIPAA Certification for its platform
Wellthy Therapeutics, a global leader in digital health and digital therapeutics, has completed its 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. These international registrations further solidify the company’s commitment to maintaining the highest standards of data security, data privacy, quality and regulatory compliance in the development and manufacturing of digital health solutions for customers in the US and worldwide, and reinforce its leadership in the SaMD space.
In addition to these recent certifications, the Wellthy Therapeutics platform is already compliant with EU MDR Class 1, ISO 13485, ISO 27001, ISO 27701, IEC 62304, and GDPR, demonstrating its dedication to delivering cutting-edge digital health solutions that consistently meet global regulatory requirements.
The platform simplifies the ability of pharma, HUBs, providers, and health plans to launch and scale globally compliant digital health and SaMD solutions. Clients leverage the platform to configure and commercialise their 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. Over 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.
Abhishek Shah, CEO, Wellthy Therapeutics, commented, “Our recent US certifications, along with our existing compliance with other international standards, reinforce our mission to revolutionize digital health worldwide. Our modular SaMD platform has enabled medication and health brands to improve patient identification and onboarding, substantially differentiate products, increase adherence and reduce the overall cost of care and medical claims; all while improving patient quality of life and solving unmet patient needs. In doing so, we are pushing the boundaries of medicine and creating a brighter future for patients around the world.”
