Our Digital Health Expertise, your SaMD Solution
We help you build the right way
First-hand experience in building Dtx/SaMD solutions for 10+ global life science partners. Digital engineering and clinical expertise in creating effective clinical care pathways for patients, caregivers, life science companies, and healthcare providers.
We navigate the regulatory hurdles for you
In-depth expertise on building, due diligence, and filing for global quality, security and software compliances(key ones – ISO-13485:2016, ISO-27000:2013, ISO-27701:2013, GDPR, MDR, IEC:62304:2006).
We set you up for real-world success
20+ clinical publications in reputed worldwide journals and 10+ real-world case studies of patients on our wellthy CARE™ platform. Enterprise clinical data management expertise to create processes for real-world data capture, analysis, and refinement.Explore our Trusted DTx Platform
Fast Tracking Discovery to Commercialization with Proven Expertise
We fast-track therapy intended use case evaluation with our vast experience in deployment, helping you identify gaps in patient-clinician drug journeys along with unmet patient needs. We also help our partners build effective communication of the intended use case so there are no ambiguities in the SaMD development journey.
We work with our partners to identify the best care pathways for the intended use case. Our in-house clinical R&D and design labs diligently work with healthcare providers, patients, and partners to create, test, and iterate on the best user journeys and clinical care pathways. We then come up with a holistic project plan.
In-house R&D labs with multi-therapy area expertise to create global guidelines-based therapies. Our labs have the end-to-end ability to run clinical case studies and trials to validate DTx solution efficacy and effectiveness.
Post design plan approval, we fast track DTx development on wellthy CARE™, our globally regulated, modular, and compliant DTx platform
SaMD’s built on wellthy CARE™ follow IEC-62304:2006 grade agile software lifecycle management process, fast-tracking the development with our clinical, user design, software engineering, and compliance expertise in adherence to internationally recognised medical device standards.
As per the intended use case and risk classification of the Software as a Medical Device(SaMD), we work very closely with our partner to conduct clinical investigations studies and pilots to generate real-world outcome data. We adhere to medical-grade safety, security, and privacy compliances to provide a robust solution to healthcare users.
We can assist you with documentation, consulting, submission, and even act as a legal manufacturer of record for a SaMD registration under FDA or MDU. From our experience of working with the world’s leading biopharmaceutical organizations, we can ensure faster regulatory approvals and also help you with formulary inclusion(Payer driven markets).
Commercialization & Support
We provide offline and online go-to-market support to our life science partners from documentation, training of reps, doctor engagement. Investing heavily in the go-to-market success, we ensure a cutting-edge user experience for patients, clinicians & providers, and all the IT infrastructure, humanized support, licensing, and data management needs are taken care of.