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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.

Our competence

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.

Take the test

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.

Download

References

MedAustron, Austria

Advanced Centre for Ion Therapy and Research

MedAustron in Austria is one of the most advanced centers for Ion Beam Therapy and Research in Europe, successfully treating patients since December 2...

See Reference

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