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