Hope Care achieves EU MDR Class IIb certification for its HC Alert platform as a medical device
- The certification validates that the information generated by the HC Alert platform complies with the required standards for medical devices
- Currently, only two companies worldwide have obtained the EU MDR Class IIb (SaMD) certification for multiple chronic diseases, and Hope Care is one of them
Hope Care, a leading company in digital healthcare solutions, is pleased to announce that it has obtained the EU MDR Class IIb certification for its HC Alert platform. This certification recognizes the platform as a medical device (Software as a Medical Device, or SaMD) and confirms that the generated information is in accordance with the highest standards required for such devices.
As a result, HC Alert establishes itself as an essential resource for healthcare professionals, ensuring that clinical data, both during and after hospitalization, meets the standards of medical quality. This enables the development of integrated care solutions, providing continuous patient monitoring in their own homes.
The confirmation that telemonitoring can now produce data of this quality allows healthcare professionals to stay continuously informed about the health status of their patients, enabling them to make more precise decisions at any time, rather than only when the patients’ health deteriorates or during follow-up visits at the hospital.
This solution brings significant efficiency gains to healthcare systems, in terms of both human resources and interoperability with the hospital system. This is particularly important at a time when healthcare systems in most countries are under enormous pressure, and the working conditions of healthcare professionals its a growing concern.
According to José Paulo Carvalho, founder, and CEO of Hope Care: “This certification granted by Tüv Rheinland confirms the quality of the work carried out at Hope Care and opens up numerous opportunities, particularly in the most demanding markets, some of which the company already operates in. The certification process took 36 months, which attests to the level of demand required for solutions of this kind.”
Hope Care’s long-term goal is to develop personalized healthcare solutions based on Generative Artificial Intelligence, taking into consideration the unique characteristics of each individual. This will significantly contribute to improving the quality of life for those who require healthcare at various stages of their lives.
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About Hope Care:
Hope Care is a technology company focused on developing innovative solutions for the healthcare sector. Its aim is to improve the quality of life for patients, facilitate the work of healthcare professionals, and promote a more efficient and accessible healthcare system. The company leverages technological advancements, such as artificial intelligence, data analytics, and connected devices, to create personalized and effective solutions. Hope Care is headquartered in Óbidos, Portugal.
Parque Tecnológico de Óbidos
Edifícios Centrais, 1.20
2510-216 Óbidos, Portugal