ISO 13485
Overview
vitalera maintains a Quality Management System (QMS) compliant with ISO 13485:2016, the international standard for quality management systems specific to the medical device industry. This QMS governs the full lifecycle of vitalera's CE-marked remote patient monitoring platform, from design through post-market surveillance.
Scope
The QMS covers:
- Design and development of medical device software
- Software lifecycle management per IEC 62304
- Risk management per ISO 14971
- Change management and configuration control
- Supplier management and procurement
- Customer feedback and complaint handling
- Corrective and preventive actions (CAPA)
Key Processes
| Process | Standard | Description |
|---|---|---|
| Risk Management | ISO 14971 | Systematic identification and mitigation of risks |
| Software Lifecycle | IEC 62304 | Development, maintenance, and retirement of software |
| Usability Engineering | IEC 62366 | User-centered design for safety |
| Clinical Evaluation | MEDDEV 2.7/1 | Evaluation of clinical data |