Healthcare Compliance

Compliance in Digital Healthcare Technologies

Digital healthcare technologies must meet strict requirements related to patient safety, data protection, and regulatory standards. Stevn Technologies collaborates with trusted healthcare technology partners whose solutions are designed for use in healthcare environments and developed in accordance with relevant technical standards and regulatory frameworks.

Healthcare Compliance

Healthcare Compliance and Standards

Healthcare technologies must comply with strict standards and regulations related to patient safety, data protection, and system reliability. Stevn Technologies collaborates with technology partners whose solutions are developed for healthcare environments and designed to support regulatory compliance and secure data handling.

Healthcare Regulations icon

Healthcare Regulations

Digital healthcare technologies must comply with regulatory requirements related to medical devices and healthcare systems.

Data Protection icon

Data Protection

Healthcare solutions must support secure handling of patient data and comply with applicable data protection regulations.

System Reliability icon

System Reliability

Technologies used in healthcare environments must be reliable and designed to support safe clinical workflows.

Patient Safety icon

Patient Safety

Digital healthcare solutions should support safe communication, monitoring, and access to information for both patients and healthcare professionals.

Regulatory Standards and Certifications

Healthcare technologies used in clinical environments must comply with strict regulatory requirements, technical standards, and data protection regulations. The technologies presented by Stevn Technologies are developed by specialized healthcare technology providers and designed in accordance with internationally recognized healthcare standards.

Medical Device Certification icon

Medical Device Certification

Certain healthcare technologies are certified medical devices developed in accordance with applicable regulatory frameworks. ECG247 is a CE-certified Class IIa medical device designed for long-term ambulatory ECG monitoring.

Healthcare Equipment Standards icon

Healthcare Equipment Standards

Healthcare hardware solutions such as FlexCare are designed according to recognized healthcare equipment standards including the EN-60601 medical electrical equipment series.

GDPR and Data Protection icon

GDPR and Data Protection

Healthcare technologies must support secure handling of sensitive patient data and comply with applicable data protection regulations including GDPR within the European Union.

Secure System Integration icon

Secure System Integration

Modern healthcare technologies are designed to integrate securely with healthcare IT systems while supporting reliable system operation.

Data Protection and Security

Healthcare technologies must support secure handling of sensitive patient data and reliable system operation. Stevn Technologies works with trusted technology partners and secure cloud infrastructure providers to ensure that digital healthcare solutions support GDPR principles and modern cybersecurity practices.

Secure Data Transmission

Healthcare technologies support secure communication between devices, applications, and healthcare systems.

Patient Data Protection

Digital healthcare systems are designed to protect sensitive healthcare information and patient data.

Secure Cloud Infrastructure

Many modern healthcare solutions rely on secure cloud infrastructure designed for medical data processing and system operation.

Access Control and Authentication

Secure authentication and user access control help ensure healthcare systems are used safely.

Secure Document Handling

Stevn Technologies utilizes privacy-focused cloud technologies such as SkyFlok secure storage for encrypted file sharing and GDPR-compliant document management.

Compliance in Our Partner Technologies

The technologies used in our solutions are developed by specialized healthcare technology providers and designed for use in healthcare environments.

FlexCare

FlexCare is a bedside patient tablet platform designed for healthcare environments.

FlexCare units are CE marked and FCC marked and developed according to healthcare equipment standards including:

  • EN-60601-1
  • EN-60601-1-2
  • EN-60068-2-75
  • MIL-STD-810G shock testing

The system also supports environmental compliance standards including RoHS and REACH.

ECG247

ECG247 is a wearable ECG monitoring solution designed for long-term heart rhythm monitoring.

The system is a CE-certified Class IIa medical device (MDD 93/42/EEC) and supports secure handling of medical data through its mobile and web-based analysis platform.

Security features include:
  • 2-factor authentication
  • secure backend infrastructure
  • GDPR compliant data handling

Talk2Care

Talk2Care is a digital communication solution designed to support patients who experience difficulty communicating verbally.

The platform helps healthcare professionals and patients communicate more effectively in clinical environments.

If you require assistance with portal access, technical guidance, or would like to explore collaboration opportunities, our team will be happy to assist.