The journey from the initial idea for a robotic system to a final, approved product throws up numerous challenges along the way. If you can orchestrate quality assurance, risk management, and standards-compliant documentation so they all harmonize well, you will be able to tame the complexity of requirements and dependencies. And we are here to help you do that with our specialized technical skills and also with our deep insight into regulatory affairs, including
- EN ISO 13485:2016 QM system
- IEC 62366-1:2015+COR1:2015+A1:2020 usability engineering
- ISO 14971:2019 risk management
- IEC 62304:2006+A1:2015 software lifecycle
- MDR:2017, FDA, IVDR regulatory affairs
- DIN EN 60601- 1:2013 medical electrical equipment safety
- IEC 80001 security
- IEC 61508 safety
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