Medical device startups and innovators, we`re with you every step of the way.
OUR APPROACH
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 egineering skills and experience.
Develop your medical device at a fixed budget.
Shorten the time to successful certification.
Minimize your overhead while you remain agile.
Leverage our egineering skills and experience.
01
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.
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.
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.
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.
We work with you to review and finalize compliance documentation. We prepare post-market surveillance documentation and procedures, and support you during clinical evaluations.
We work with you to review and finalize compliance documentation. We prepare post-market surveillance documentation and procedures, and support you during clinical evaluations.
Engineering in compliance with medical device regulations
We are with you every step of the way.
REGULATIONS
Engineering in linewith 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 1348, ISO 9001
Standards for medical device development
IEC 60601 family, ISO 14971, IEC 62304, IEC 62366
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
KNOWLEDGE
Our know-how
We are with you every step of the way.
Domains
Radiation Therapy, Medical Imaging, In Vitro Diagnostic, Medical Robotics, Patient Monitoring, Patient Positioning, Motion Control, Image guided automation, Machine vision
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
Contact information
If you’re looking for some information that you couldn’t find anywhere else on the website, don’t hesitate to contact us.
We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept”, you consent to the use of ALL the cookies.
These cookies are necessary for the correct functioning of our website, and they shouldn\'t be blocked from being set by our system. They are usually only set up in response to the services you use on our site, such as signing in, filling out forms, and setting privacy options. You may set your browser to block or notify you of these cookies, but this may cause some of our website\'s components to fail. These cookies do not store personal information.
These cookies can be set on our site by our advertising partners and allow us to count visits and the origin of web traffic, thus measuring and improving the condition of our website. They can be used by the mentioned partners to build a profile of your interests and display to you relevant ads on other sites. These cookies do not store personal information but are based on the unique identification of your browser and internet device. If you do not allow these cookies, you will receive less targeted advertising.