MDR Compliance
Overview
vitalera is developed as Medical Device Software (MDSW) under the EU Medical Device Regulation (MDR 2017/745). The platform is designed for software intended for medical purposes that provides information used to make clinical decisions.
What This Means
- The platform meets all General Safety and Performance Requirements (GSPR) of Annex I
- Technical documentation follows the STED (Summary Technical Documentation) format
- A comprehensive Quality Management System is maintained per ISO 13485
Regulatory Documentation
| Document | Status | Description |
|---|---|---|
| STED Documentation | Complete | Full technical documentation package |
| AEMPS Registration | Registered | Spanish Agency of Medicines and Medical Devices |
Technical Documentation
vitalera maintains complete technical documentation including:
- Risk management file (ISO 14971)
- Software lifecycle documentation (IEC 62304)
- Usability engineering file (IEC 62366)
- Clinical evaluation
- Post-market surveillance plan
For Clients
vitalera has been developed and validated under the MDR 2017/745 regulatory framework. The platform's FHIR R5 API, native SDKs for Android and iOS, and clinical workflow tools have all been built with this regulatory framework in mind, ensuring that healthcare organizations in the European Economic Area can integrate vitalera with confidence in its safety and data integrity standards.