Wellthy therapeutics Pvt. Ltd, a Software as Medical Device (SaMD) company remains compliant to EU MDR 2017/745 regulatory requirements and achieves Class 1 CE marking for the Wellthy Care™ Platform’s medication reminder utility.
Wellthy care medication reminder utility provides a high level of protection of health for patients with Chronic diseases by improving their quality of life and sets a high standard of quality and safety as a part of Class I medical devices by helping patients set-up medication intake reminder themselves to take their medication in time and for set duration (self-administered by patients).
CE marking process indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health and environmental protection requirements.
Wellthy Care App is intended for a patient population above 18 years of age and can be used for therapeutic areas or medical indications across chronic diseases. A patient or user of the application can use the medication reminder utility based on the Doctor’s advice thus ensuring Medication adherence. This information can be further shared with the care provider/clinician to improve the richness of a consultation.
“ A Class I Medical Device Classification of our Wellthy CARE™ platform opens up possibilities for the European Market and I would like to congratulate our Technology and Product teams for adding one more Feather to our cap” – Abhishek Shah, CEO, Wellthy Therapeutics.
About Wellthy Therapeutics
Wellthy Therapeutics is a leading digital therapeutics (DTx) company working across Europe and Asia with the mission to bridge the gap for better health outcomes, by enabling digital care for complex clinical conditions.
The company’s proprietary platform Wellthy CARE™ , CE Mark I Medical Device, helps to prevent, manage or treat complex clinical conditions. It works closely with pharmaceutical companies, medical device manufacturers, Insurers (payors) , and health (hospital) systems to design and deploy clinically validated digital therapeutic solutions to achieve real-world clinical and business outcomes across multiple therapeutic areas. The platform works to deliver outcome, adherence and risk reduction solutions, all with the patient / end user at the centre.
Individual Digital Therapeutic solutions in the company’s portfolio cover Type II Diabetes, Cardiology, Women’s Health, Respiratory and Select Rare Diseases. Real World Evidence across these therapeutic conditions are showcased through over 20+ clinical publications, by working with global healthcare partners helping patients in over 600 cities worldwide.
For more information, visit www.wellthytherapeutics.com