As medical device engineering specialists, we help MedTech startups from planning to developing their device. Our team of 200+ engineers makes sure that the development is done at a fixed budget and in line with medical device regulations. With 20+ years of experience we serve partners across the globe.
We take care of the complexities behind medical device engineering
1. Product Definition & Planning
Together with you we set out the requirements and specifications of your medical device. We plan the development steps and prepare regulatory approval pathway in detail; with exact deliverables, milestones, and budgets. We can also assist with QMS design and implementation.
2. Development & Engineering
We design, engineer, verify, and validate your medical device. Our engineers write all necessary compliance documentation to ensure quality, safety and performance of your medical device.
3. Transfer to Manufacturing
We prepare all the documentation necessary for efficient manufacturing and sourcing. We work with certified OEMs to ensure smooth production start and ramp-up.
4. Regulatory Compliance
We work with you to review and finalize compliance documentation and support you throughout regulatory approval process.
Engineering in line with medical device regulations
Our team helps you reach compliance with medical device regulations and standards.
With 20+ years of experience and domain know-how in medical imaging, radiation therapy, medical robotics, patient monitoring, and patient positioning, we serve partners across the globe. We invite you to see the list of our clients.
We're part of Cosylab, world’s leading provider of control systems
Cosylab is the world’s leading provider of control systems for the planet’s most complex machines; nuclear accelerators, optical and radio telescopes, fusion reactors, cancer therapy systems, and much more. ArrowFast™ is a medtech initiative of Cosylab Switzerland GmbH to coordinate experts from several locations worldwide.