WE DRIVE YOUR MEDICAL INNOVATION
From Idea to Market
OUR MEDICAL ENGINEERING SERVICES
MECHANICAL SYSTEMS
EMBEDDED SYSTEMS
MOBILE APPLICATIONS
WEB/CLOUD APPS
LEARN MORE ABOUT EACH SERVICE BELOW
RAPID PROTOTYPING
IS THE IDEA CLEAR?
We build working prototypes using evaluation or emulated hardware and open-source software to help you quickly validate and assess ideas from technical, financial, and regulatory perspectives.
DEVELOPMENT
FROM IDEA TO PRODUCT
- IEC 62304 Software Lifecycle Processes
- ISO 14971 Risk Management
- IEC 81001 Cyber Security
- IEC 62336 Usability
- IEC 60601 Patient Electrical Safety
- IEC 61010 Equipment Electrical Safety
- HIPAA / GDPR Personal Health Data Protection
CONTINOUS QUALITY
IS IT GOOD? WHAT'S NEXT?
Automated testing with CI/CD pipeline design and setup Intelligent dashboards can show project, process, and product quality.
REGULATORY COMPLIANCE SUPPORT
PRODUCT CERTIFICATION
We support companies throughout their regulatory journey, from ISO 13485-compliant QMS implementation, regulatory process definition, and technical documentation preparation to regulatory consulting & compliance guide, pathway assessment, product registration support, and strategic & financial evaluation.
MANUFATURING
CERTIFIED PARTNERS FOR MEDICAL DEVICE PRODUCTION
Product Design
SMD Assembly/Soldering
Final Assembly/Testing
Warehouse & Packaging
Injection Molding
Quality Assurance/Laboratory
Sample Track Record
Ventilator
Pulse Oximeter
Syringe Pump
