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.

Stephen Towe

CEO, Leo Cancer Care

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.

Fritz DeJongh

CEO, Proton VDA

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

LET US HELP YOU GET YOUR MEDICAL DEVICE TO THE MARKET

ArrowFast Engineers for Medical Device Development. Doing it right the first time.

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