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ArrowFast AG
Technopark Aargau Badenerstrasse 13,
5200
Brugg
Switzerland
Switzerland
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Our range of products
Product categories
- 03 Services
- 03.02 Consulting (services)
- 03.02.01 Market access, internationalization
Market access, internationalization
- 03 Services
- 03.02 Consulting (services)
- 03.02.04 Regulatory affairs
Regulatory affairs
- 03 Services
- 03.02 Consulting (services)
- 03.02.05 Documentation
Documentation
- 03 Services
- 03.04 Design and development
- 03.04.01 Product design, product development
Product design, product development
Our products
Product category: Market access, internationalization
From product definition to commercialization
Medical device startups and innovators, we`re with you every step of the way.
- Develop your medical device at a fixed budget.
- Shorten the time to successful certification.
- Minimize your overhead while you remain agile.
- Leverage our engineering skills and experience.
Product category: Product design, product development
Product Definition, Development & Engineering
Product Definition
Your optimal development path starts with careful planning. We plan your medical device development and certification pathway carefully and in detail; with exact deliverables, milestones, and budgets.
SERVICES:
Development & Engineering
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.
SERVICES
Your optimal development path starts with careful planning. We plan your medical device development and certification pathway carefully and in detail; with exact deliverables, milestones, and budgets.
SERVICES:
- Technical Reviews and Development
- Regulatory Compliance Advice
- Requirements Specification
- Verification and Validation Planning
- System Architecture Analysis and Advice
Development & Engineering
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.
SERVICES
- System Design
- Prototyping
- Engineering Services
- Usability Design and Engineering
- System Integration
Product category: Documentation
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.
SERVICES
SERVICES
- Verification & Validation
- Testing
- Product and User Documentation
- Medical Compliance Documentation
- Device Support and Maintenance
Product category: Regulatory affairs
Engineering in line with medical device regulations
When developing a medical device, safety comes first.
- Medical device regulations
EU MDR, USA FDA, China NMPA & Other countries - Quality management system
ISO 13485, ISO 9001 - Standards for medical device development
IEC 60601 family, ISO 14971, IEC 62304, IEC 62366
Company news
Date
Topic
01 Oct 2020
We spoke to Niek Schreuder about Bringing Innovative Solutions to the Medical Device Market
1 October 2020 - We`ve started our own MedTech Chats series this October. The pimary goal is to provide useful content to all medical device innovators, and to ease their way on the way to bringing novel medical devices to market.
We`ve started the series with one of the pioneers of proton therapy, Niek Schreuder. We invite you to listen to the interview, and learn from the expert.
"I 100% believe in the medical industry. We need to all be enablers, to say: Yes. Here's what I built. I mean you can't have my stuff. You can't have my designs, but let's take on that challenge and see if you can come and build something better because who's benefiting at the end? It is the patient. And it's the industry and that's really what we need to focus on, " is one of the wisdoms you will hear form Niek Schreuder.
We`ve started the series with one of the pioneers of proton therapy, Niek Schreuder. We invite you to listen to the interview, and learn from the expert.
"I 100% believe in the medical industry. We need to all be enablers, to say: Yes. Here's what I built. I mean you can't have my stuff. You can't have my designs, but let's take on that challenge and see if you can come and build something better because who's benefiting at the end? It is the patient. And it's the industry and that's really what we need to focus on, " is one of the wisdoms you will hear form Niek Schreuder.
20 Jul 2020
ArrowFast Supports Positrigo AG in Development of PET Scanner for Affordable Early Diagnosis of Alzheimer
Brugg, 20 July 2020 - ArrowFast, a medical device software, and solution provider is helping Positrigo develop a compact brain positron emission tomography scanner. The new PET scanner ‘NeuroLF’ will be used for efficient, low-cost early detection of brain diseases, such as Alzheimer’s Disease. PET scanners make it possible to provide patients an evaluation of the risk to develop Alzheimer’s Disease more than 10 years before the symptoms appear.
Positrigo is building an affordable device that will be by order of magnitude less expensive than the current PET scanners. Furthermore, its affordability and compact design have the potential to extend the scanner’s application to multiple fields of use.
“We were looking for an imaging medical device specialist with the capabilities to help us deliver a very complex medical product, comprising Electronics and Software, without compromising for quality, safety, and performance. We chose Cosylab’s ArrowFast for their track-record in medical device systems, their broad skill set in radio-oncology, and their battle-tested medically compliant development processes. We are confident that in a partnership with ArrowFast we can bring our PET scanner to the patients faster”, explains Dr. Jannis Fischer, Positrigo CEO.
“We are honoured to be chosen by Positrigo as their technology partner. Venturelab positioned them as one of the 10 Swiss MedTech startups to watch in 2020, and Drs. Fischer and Ahnen were on the Forbes list “30 under 30” in Science and Healthcare 2018. They also received the prestigeous EIC Accelerator grant (up to € 2.2 million), . . . it is our privilege to be entrusted to participate in a project with a potential to disrupt medical imaging”, ads Igor Rogelj, the Head of ArrowFast.
About Positrigo
Dementia is a major problem in our aging societies costing nearly a trillion USD worldwide per year. Treatments are on the horizon, but an affordable and widely available diagnostic technique is still missing. Positrigo’s brain positron emission tomography system offers functional brain imaging to everyone at a fraction of today’s cost. Based on a prototype developed at ETH Zurich, Positrigo strives for the certification of it’s imaging system NeuroLF as a medical device under CE and FDA regulations, and to enter the markets by 2022/23. https://www.positrigo.com/
Positrigo is building an affordable device that will be by order of magnitude less expensive than the current PET scanners. Furthermore, its affordability and compact design have the potential to extend the scanner’s application to multiple fields of use.
“We were looking for an imaging medical device specialist with the capabilities to help us deliver a very complex medical product, comprising Electronics and Software, without compromising for quality, safety, and performance. We chose Cosylab’s ArrowFast for their track-record in medical device systems, their broad skill set in radio-oncology, and their battle-tested medically compliant development processes. We are confident that in a partnership with ArrowFast we can bring our PET scanner to the patients faster”, explains Dr. Jannis Fischer, Positrigo CEO.
“We are honoured to be chosen by Positrigo as their technology partner. Venturelab positioned them as one of the 10 Swiss MedTech startups to watch in 2020, and Drs. Fischer and Ahnen were on the Forbes list “30 under 30” in Science and Healthcare 2018. They also received the prestigeous EIC Accelerator grant (up to € 2.2 million), . . . it is our privilege to be entrusted to participate in a project with a potential to disrupt medical imaging”, ads Igor Rogelj, the Head of ArrowFast.
About Positrigo
Dementia is a major problem in our aging societies costing nearly a trillion USD worldwide per year. Treatments are on the horizon, but an affordable and widely available diagnostic technique is still missing. Positrigo’s brain positron emission tomography system offers functional brain imaging to everyone at a fraction of today’s cost. Based on a prototype developed at ETH Zurich, Positrigo strives for the certification of it’s imaging system NeuroLF as a medical device under CE and FDA regulations, and to enter the markets by 2022/23. https://www.positrigo.com/
28 Apr 2020
Cosylab launches a new initiative ArrowFast
Ljubljana, 28 April 2020 – Today, Cosylab announces a new initiative, the ArrowFast Medical Device Engineering, which empowers startups to develop their new medical devices faster and more accurately, solves complexity behind the development, and brings the result – a certified medical device, in time.
Mark Plesko, Chairman at ArrowFast and CEO at Cosylab, revealed: “I am proud to work with colleagues that always explore and find new ways to help save people’s lives. As a world leader in providing control systems for most complex machines, such as nuclear accelerators and cancer therapy systems, we have found ourselves in a unique position to help innovators bring their innovations to the market faster. Given our mission to contribute to society’s progress and humanity, and our extensive experience in regulations and certifications, it was only natural to offer our expertise to all the emerging medical device startups out there.”
The “why” and “what” are always perfectly defined by medical device innovators, and the “how” is often perceived as easily manageable, until that moment when they realize that there is a lack of software, regulatory, and business knowledge in their team.
ArrowFast was created to ease their pain, and help them place all the pieces of the puzzle together. The team of experts will help them plan, develop, and certify their medical device in time and within a fixed budget, while allowing the innovators to focus on their innovation and clinical benefits to improve patient outcomes.
Igor Rogelj, Head at ArrowFast, explains: “As we are experiencing a pandemic time with Covid-19, we rushed with the launch of ArrowFast. Our purpose after all is to facilitate innovation in the MedTech and Healthcare market.”
He emphasizes: “What I personally see as our main contribution is the fact that we possess years of experience and knowledge and have processes in place to develop and certify medical devices. Such experience is crucial to a startup’s success – for the successful certification of its medical device and the launch of the device as a viable new product on the healthcare market.”
Mark Plesko, Chairman at ArrowFast and CEO at Cosylab, revealed: “I am proud to work with colleagues that always explore and find new ways to help save people’s lives. As a world leader in providing control systems for most complex machines, such as nuclear accelerators and cancer therapy systems, we have found ourselves in a unique position to help innovators bring their innovations to the market faster. Given our mission to contribute to society’s progress and humanity, and our extensive experience in regulations and certifications, it was only natural to offer our expertise to all the emerging medical device startups out there.”
The “why” and “what” are always perfectly defined by medical device innovators, and the “how” is often perceived as easily manageable, until that moment when they realize that there is a lack of software, regulatory, and business knowledge in their team.
ArrowFast was created to ease their pain, and help them place all the pieces of the puzzle together. The team of experts will help them plan, develop, and certify their medical device in time and within a fixed budget, while allowing the innovators to focus on their innovation and clinical benefits to improve patient outcomes.
Igor Rogelj, Head at ArrowFast, explains: “As we are experiencing a pandemic time with Covid-19, we rushed with the launch of ArrowFast. Our purpose after all is to facilitate innovation in the MedTech and Healthcare market.”
He emphasizes: “What I personally see as our main contribution is the fact that we possess years of experience and knowledge and have processes in place to develop and certify medical devices. Such experience is crucial to a startup’s success – for the successful certification of its medical device and the launch of the device as a viable new product on the healthcare market.”
About us
Company portrait
As medical device software engineers, we help MedTech startups get to their next milestone. Our in-house team of 220 engineers helps startups from planning to developing their device and making sure it's certified for the targeted market.
OUR SERVICES:
From product definition to commercialization
Product Definition
ArrowFast is a trade mark of Cosylab – 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.
OUR SERVICES:
From product definition to commercialization
Product Definition
- Technical Reviews and Development
- Regulatory Compliance Advice
- Requirements Specification
- Verification and Validation Planning
- System Architecture Analysis and Advice
- System Design
- Prototyping
- Engineering Services
- Usability Design and Engineering
- System Integration
- Verification & Validation
- Testing
- Product and User Documentation
- Medical Compliance Documentation
- Device Support and Maintenance
ArrowFast is a trade mark of Cosylab – 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.
Company data
Number of employees
100-499
Area of business
Services
