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We specialize in medical device consulting. We have experience in and consult for the following areas of medical device design and development:
Safety and Performance
IEC 60601-1 and Collateral Standards
General Requirements
Electromagnetic Compatibility
Alarm Systems
Medical Software
Life Cycle Processes (IEC 62304)
Configuration Management
Biocompatibility
Biological Evaluation (ISO 10993)
Breathing Gas Pathway (ISO 18562)
System Safety
Risk Management (ISO 14971)
Hazard Analysis
Failure Modes Effects Analysis (FMEA)
Fault Tree Analysis
Human Factors
Usability Engineering (62366)
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