The steps to developing your medical device
PLAN
You optimal development path starts with careful planning. We review and optimize system architecture, define design inputs, as well as system and user requirements. Test plan for verification, and validation is set in detail. Exact deliverables, milestones, and budgets are prepared for the Development Phase.
Our Services
Technical Reviews and Development Planning
Regulatory Compliance Advice
Requirements Specification
Verification and Validation Planning
System Architecture Analysis and Advice
Project Management
DEVELOP
Experience in engineering leads to efficient execution. We undertake design work, hardware, software, and usability engineering together with necessary verification and validation activities. Quality assurance, risk mitigation, safety, and diligent compliance documentation activities underscore the whole development path.
Our Services
System Design (hardware, software, firmware, mechanical)
Prototyping
Engineering Services (hardware, software, firmware, mechanical)
Usability Design and Engineering
System Integration
CERTIFY
We advise on the optimal pathway for successful device certification. We work with you to review and finalize compliance documentation. We prepare post-market surveillance documentation and procedures, and support you during clinical evaluations.
Our Services
Verification, Validation and Testing
Product and User Documentation
Medical Compliance Documentation
Device Support and Maintenance
In-House Knowledge and Modules
Domain Knowledge
Radiation Therapy, Oncology, Radiology, Medical Imaging, Diagnostic, Robotics, Wearables, Patient Monitoring, Tele-medicine
Experience
Patient Positioning, Motion Control, Robotics, Machine Vision, Radiation, Spectroscopy, Detectors, DAQ, LaserTech, Cloud, AI, Big Data, IoT, Data Monitoring & Analysis, System Integration, VR, AR
Modules
Workflow Manager, Patient Scheduling, Medical Safety System, Treatment Planning, Treatment Control Systems, Oncology Information System, Radiology Information System, Accelerator Control Systems, Dose Delivery System
SkillS
Hardware/Electronics, IT Software, Control Systems, Usability Systems, User Interface (UX/IX), Mechanical Design, 3D Printing
Standards
Quality management system
ISO 12485, ISO 9001
Medical development standards
IEC 60601 family, ISO 14971, IEC 62304, IEC 62366
Medical device regulations
EU MDR, USA FDA, China NMPA & other countries
