How long will it take to get your medical device on the market?
DON’t LET
THEM WAIT!
PLAN, DEVELOP AND CERTIFY YOUR MEDICAL DEVICE WITH US.
ArrowFast Medical Device Engineers.
WHY US
Partner with ArrowFast to develop your device at a fixed budget, certify in time, and be first on the market.
Work with ArrowFast to develop your device at low cost, minimize overheads, and remain agile.
Leverage Cosylab’s credibility, engineering skills, and proven medical development processes.
Keep focus on your innovation and clinical benefits to improve patient outcomes.
STANDARDS
Quality Management System
ISO 13485, 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
REGULATIONS
INDUSTRY ASSOCIATIONS
OUR APPROACH
Plan
We plan your medical device development and certification pathway carefully and in detail; With exact deliverables, milestones, and budgets.
Develop
We design, engineer, verify and validate your medical device. Quality assurance, safety, risk mitigation and diligent compliance documentation will underscore your development path end to end.
Certify
We advise and work with you every step along the optimal pathway to successful device certification.
WE ARE ENGINEERS FOR MEDICAL DEVICE INNOVATORS
ArrowFast Medical Device Engineers is a strike team, formed at Cosylab and dedicated to bringing medical devices to the market quickly. We draw from a large pool of in-house engineers for software and hardware, mechanical engineers, manufacturing and machine-building experts, physicists, mathematicians, medical experts, spanning three continents.
In-House Developers and Engineers
PhD Holders from STEM Fields
Locations Worldwide
Years of Experience
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
Leo Cancer Care decided to work with Cosylab and ArrowFast due to their flexibility and willingness to really become part of our team. Cosylab and ArrowFast have a huge amount of experience developing complex software for the heavily regulated medical field. This experience means they have a deep level of understanding when it comes to appropriate system architecture and the necessary regulatory deliverables.
Working with Cosylab and ArrowFast has been a real partnership and one that has allowed us to leverage the vast experience of their HW and SW engineers to dramatically reduce our time to market.
Moving our novel medical imaging system from the prototype stage into the clinic requires a set of skills in systems engineering, integration, regulatory practice, and marketing. Cosylab and Arrow Fast have brought these skills to our partnership and they have proved critical for growing our business at Proton VDA and opening new markets.
Their detailed understanding of patient safety aspects and device usability combined with broad experience and expertise in proton therapy instrumentation and controls enabled a rethinking of our system architecture and integration with treatment rooms. Their diligent and rigorous following of regulatory practices give us the confidence ahead for the certification process. Their extensive contacts in the radiation therapy industry are helping us work with clinical groups to plan ahead for the use of our technology for improved patient care.
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