Prosoma, an international venture providing digital therapeutics designed specifically for oncology is now compliant with the requirements of Directive 93/42 for Class I medical devices.
Living Well adheres to the requirements of the Medical Devices Directive 93/42/EEC. The Directive sets out standards, outlines safety and performance requirements, and ensures the quality required by medical devices in the UK & EU.
Living Well is a digital health platform intended to improve patients’ quality of life and reduce stress, anxiety, and depression symptoms related to cancer diagnosis and treatment at different stages of cancer. The application is dedicated to adult cancer patients, their care givers, and cancer survivors.
This is a fantastic step forward for Prosoma, which will enable further growth and expansion in the digital health industry. The last 18 months have particularly highlighted the importance of healthcare that can be delivered from a distance. Cancer patients have been one of the most affected groups as hospital spaces and services have been taken up due to the pandemic. Living Well will enable cancer patients to access Cognitive Behavioural Therapy (CBT), manage stress, track their emotional health, and source tips from fellow patients - all from the comfort of their homes.
Piotr Grudziński, Prosoma’s COO, commented: “It’s an absolute step in the right direction. Through this process, we hope to develop a solution that will be available to all cancer patients at all stages of treatment.
In the past few years, we have seen that resources in mental health are scarce and often it is not possible for patients to gain access when they need it the most. Now that our software is in the process of being classified as a medical device, we will seek to bridge that gap and ensure that no patient is left behind.”
This crucial step will enable further development in digital solutions for cancer patients, leading to a better quality of life and coping mechanisms that patients can use at any time and from anywhere.
Germany differentiates lifestyle applications from medical applications by calling them DiGA, which is an abbreviation for Digitale Gesundheitsanwendungen,