Cuviva receives MDR certification – paves the way for international growth

The Cuviva RPM Platform is now certified according to MDR Class IIa. This makes Cuviva RPM Platform one of the first complete platforms certified according to MDR Class IIa for Remote Patient Monitoring and Hospital at Home. The certification demonstrates increased patient safety and efficiency of healthcare, and opens up for further extensive development.

The new EU Medical Device Regulation (MDR), which entered into force in May 2021, involves comprehensive changes in the requirements for medical devices and medical device software. The motive of the new regulation is increased patient safety and increased requirements to demonstrate the clinical benefit of the product.

Cuviva’s platform is a complete Remote Patient Monitoring platform paving the way for Virtual Wards and Hospital at Home. Cuviva Remote Patient Monitoring (RPM) Platform 3.1 is one of the first complete software platforms certified according to MDR Class IIa. This provides healthcare providers with assurance of high-quality software and increased patient safety when moving healthcare into the patient’s home.

“Cuviva has the largest number of customers, the most complete software platform, and greatest width of application for Remote Patient Monitoring and Hospital at Home in Sweden, our home market. We are also a leader in the European market. I’m very proud of how we, in close cooperation with our customers, have developed the Cuviva RPM Platform over the past six years. The positive feedback and praise we receive from our customers is very rewarding. We can provide them with the most complete platform for digital transformation in setting up virtual wards,” said Henrik Cederqvist, CEO and co-founder of Cuviva.

“The MDR Class IIa certification of Cuviva RPM Platform provides customers with additional safety and security for both patients and healthcare providers. It shows that the Cuviva platform has been externally reviewed and approved as medical device software. The certification will also open cooperation with Pharma and MedTech Companies.”

The Cuviva RPM Platform enables healthcare providers to set up virtual wards and to monitor patients remotely. Examples of areas of use for Remote Patient Monitoring where the benefits are most immediate are heart failure, COPD, hypertension and diabetes. Cuviva RPM Platform also provides caregivers with tools for collaboration and decision support enabling them to focus on the patients with the greatest needs.

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