JSP MEDICAL DEVICES · Independent division within JSP HOLDING
JSP MEDICAL DEVICES — Quality, safety & compliance
Careful medical product development requires a systematic quality and risk approach, adapted to the device type and market.
EU and international requirements
When introducing a product to the European market, it must be determined whether the EU-MDR/IVDR applies. The classification partly determines which assessment, documentation, and conformity procedure are required.
Quality system and standards
Relevant frameworks may include, for example, ISO 13485, ISO 14971, and for medical software, IEC 62304. Whether and how they apply must be assessed for each intended use.
Cybersecurity and clinical evidence
Data protection, risks of erroneous outputs, post-release changes, incident management, and clinical evaluation must be demonstrably appropriate.
Our accountability
We explicitly distinguish between medical intended uses, general information technology, prototype research, and an officially authorized product. Patients and healthcare professionals should not derive undue trust from attractive visualizations.
Current status
No CE marking, notified body, medical approval, or implemented certified quality management system demonstrated.