We deliver safety focused solutions for complex medical devices in critical care, defibrillation and monitoring.

Development

Creating complex medical devices or costumized modules

• Finding best product market fit
• Process designed to get ready to market
• Develop high end medical solutions
• Experienced integration team
• Saving development costs with our modular system
• Network of experts to overcome challenges

Overview Development Services

• Hardware:
  PCB Layout, Controller, Housing, Sensors, Prototyping, Mass Production design
• Software:
  Embedded System Platform, Connectivity ECG Algorithms, System Architecture
• Functional safety:
  Automated Testing, EMC

Consulting

Making Regulatory Affairs as efficient as it gets

• Regulatory Approval service
• Easier from NMPA to CE or FDA approval

Getting your devices equipped with the right technology
for best market fit

• Support & reviews to fit product requirements
• Expertise in high voltage & vital signs sensors

Overview Consulting Services

• QM/RA:
  Gap analyses for technical documentation, approval support MDR / FDA, ISO 13485 compliant QM system
• R&D:
  System footprint workshop, proof of concept, cyber security, automated testing, ECG customization & software algorithms