MEASURING EQUIPMENT & CLASSIFICATION
For people with long-term or chronic illness, it is important that follow-up does not only apply to medical parameters. ImagineCare’s solution therefore also collects health data from validated rating scales and the patient’s perceived quality of life.
Classifications and standards
ImagineCare’s platform has been developed from the start with quality in focus. Our strong focus on quality is also evident in our quality management system. Our product is currently classified as MDD class 1 and we follow the requirements in SOSFS 2008:1. We will also certify our product according to MDR, the new regulation for medical devices. ImagineCare applies to the following standards:
- Quality, ISO 13485 (Medical devices – Quality Management Systems)
- Software development, IEC 62304 (Medical device software – Software life cycle processes)
- Security, ISO / IEC 27001 (Information security, cybersecurity and privacy protection)
- Risk, ISO 14971 (Risk management for medical devices)