Regulatory Status
Compliant and Trustworthy
At Cuviva, we are fully committed to upholding the highest standards of compliance with healthcare regulations and industry standards. Our approach to regulatory compliance is proactive and comprehensive, ensuring that our digital solutions meet all applicable legal requirements.
GDPR Compliance and Information Security
We adhere strictly to the General Data Protection Regulation (GDPR), which governs how personal data is collected, processed, and stored. This includes obtaining explicit consent from users for data processing and ensuring that individuals can exercise their rights regarding their personal information. The Cuviva RPM Platform is developed with the patient data security in mind and by using our platform you could protect the patient´s and employee´s data. The Cuviva RPM Platform helps you to stay compliant with GDPR.
Cuviva has also implemented an Information Security Mangement system including all processes from software development, maintenance and service. The Information security Mangement system is certified by Qvalify.
Medical Device Certification under MDR
Cuviva RPM Platform is certified by BSI as a MDR Class IIa medical device since 2022. The technical documentation and clinical evidence for our platform meet the stringent requirements set forth by the EU Regulation 2017/745 (MDR).
Quality Management Systems
Cuviva has implemented a Quality Management System according to ISO 13485:2016 and it is certified by BSI. Cuviva RPM Platform is developed according to software development standard(IEC 62304:2006/AMD1:2015). We also focus on user-friendly design as outlined in IEC 62366-1:2015, ensuring our solutions are not only effective but also accessible.
Compliance and Safety
Cuviva’s platform is designed with patient data safety as a top priority. The compliance module ensures adherence to regulatory standards (GDPR, ISO 27001 and 13485), while secure data storage and user access controls protect patient information and maintain confidentiality.
Would you like to find out more about Cuviva’s regulatory status? Get in touch with us!