Professional Service
Medical Device Engineering
Software & Hardware Development and Engineering
On-time, within-budget and according to medical standards
No matter the technology or complexity of your medical device, we are here to take full responsibility – from the early stages of product development to clinical use and beyond.
We can offer you our services, where we can lend you our expertise, or offer complete solutions, where we take full responsibility for the delivered product, including CE/FDA/CFDA marking.
How can we help you
Project Management & Consulting
Ensuring on-time and within budget delivery
Analysis & Requirement Specifications
Joining forces with you in the process of decomposing user needs to the most low-level requirements.
System design & Architecture
Defining the architecture, modules, interfaces, and data for a system to satisfy the specified requirements
Software & hardware engineering & system integration
No matter the technology
Verification & Validation
From planning to execution
Support & maintenance
We offer full support and maintenance for your medical device project
Key Benefits For You
Elimination of development and technological risks
A shorter time-to-market
Reduced overall investment
CE, FDA and CFDA Medical certification
Access to a large pool of experts with relevant knowledge
Full training of your staff or your customers and technical support
Quality Assurance
Quality Management System:
ISO 13485
Medical Development Standards:
IEC 60601 family, ISO 14971, IEC 62304, IEC 62366
Medical Device Regulations:
EU MDR, USA FDA, China NMPA & other countries
We can help you with all aspects of the project lifecycle
From project management to support and maintenance, no matter the technology you use.
Look at our competence for a better idea of the areas in which we can help you.
Medical Device Development: Do you know it all?
The test will help you assess your understanding of essential aspects in a development project addressing an active medical device equipped by software. Answer the 16 questions to see how well you understand the crucial regulatory, development, and business matters.
Download
Medical Software Development and Engineering brochure
Want to have an easy-to-reference summary of our services in Medical Software Development and Engineering?
Download brochure.
References
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Positrigo, Switzerland
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Positrigo is a company dedicated to the development, production, and sales of dedicated brain positron emission tomography (PET) scanners.
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